Heart Failure With Preserved Ejection FractionPhase 3PARAGON-HFNCT01920711
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
A Phase 3 study testing LCZ696 and Valsartan in people with Heart Failure With Preserved Ejection Fraction, run by Novartis Pharmaceuticals at 715 sites in 43 countries.
Trial summary
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- LCZ696 and Valsartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,822 participants
- Where
- 715 sitesin 43 countries
- Study dates
- 18 Jul 2014to 7 Jun 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
- Current symptom(s) of HF (NYHA class II-IV)
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- Elevated NT-proBNP
Who cannot join
- Any prior measurement of LVEF < 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
- Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
- Current acute decompensated HF requiring therapy.
- Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
715 sites in 43 countries.
715 sites in 43 countries
United States110 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Ann Arbor, Michigan, 48105
Novartis Investigative Site
Atlanta, Georgia, 30309
Novartis Investigative Site
Atlanta, Georgia, 30310-1495
Novartis Investigative Site
Baltimore, Maryland, 21229
Novartis Investigative Site
Baltimore, Maryland, 21287
Novartis Investigative Site
Baton Rouge, Louisiana, 70808
Novartis Investigative Site
Beaumont, Texas, 77702
Novartis Investigative Site
Belzoni, Mississippi, 39038
Novartis Investigative Site
Beverly Hills, California, 90211
Novartis Investigative Site
Biddeford, Maine, 04005
Novartis Investigative Site
Boston, Massachusetts, 02118
Novartis Investigative Site
Boston, Massachusetts
Novartis Investigative Site
Bradenton, Florida, 34209
Novartis Investigative Site
Brooklyn, New York, 11215
Novartis Investigative Site
Buffalo, New York, 14203
Novartis Investigative Site
Buffalo, New York, 14215
Novartis Investigative Site
Canton, Ohio, 44710
Novartis Investigative Site
Chapel Hill, North Carolina, 27599-7075
Novartis Investigative Site
Charleston, South Carolina, 29403
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Chicago, Illinois, 60637
Novartis Investigative Site
Columbia, Maryland, 21044
Novartis Investigative Site
Covington, Georgia, 30014
Novartis Investigative Site
Cumming, Georgia, 30041
Novartis Investigative Site
Dallas, Texas, 75216
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Dallas, Texas, 75235
Novartis Investigative Site
Denver, Colorado, 80220
Novartis Investigative Site
Detroit, Michigan, 48202
Novartis Investigative Site
Evanston, Illinois, 60201
Novartis Investigative Site
Flushing, New York, 11355
Novartis Investigative Site
Gainesville, Florida, 32608
Novartis Investigative Site
Grand Blanc, Michigan, 48439
Novartis Investigative Site
Grand Forks, North Dakota, 58201
Novartis Investigative Site
Hammond, Louisiana, 70403
Novartis Investigative Site
Hartford, Connecticut, 06105
Novartis Investigative Site
Hazel Crest, Illinois, 60429
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Houston, Texas, 77094
Novartis Investigative Site
Huntsville, Alabama, 35801
Novartis Investigative Site
Jackson, Mississippi, 39216
Novartis Investigative Site
Kalispell, Montana, 59901 3158
Novartis Investigative Site
Kingston, New York, 12401
Novartis Investigative Site
Knoxville, Tennessee, 37917
Novartis Investigative Site
Lafayette, Louisiana, 70508
Novartis Investigative Site
Lake Worth, Florida, 33461
Novartis Investigative Site
Lebanon, New Hampshire, 03756
Novartis Investigative Site
Lincoln, Nebraska, 68506
Novartis Investigative Site
Little Rock, Arkansas, 72204
Novartis Investigative Site
Livingston, Texas, 77351
Novartis Investigative Site
Lombard, Illinois, 60148
Novartis Investigative Site
Los Angeles, California, 90073
Novartis Investigative Site
Louisville, Kentucky, 40206
Novartis Investigative Site
Madison, Wisconsin, 53705
Novartis Investigative Site
Madison, Wisconsin, 53792-1615
Novartis Investigative Site
Marion, Ohio, 43302
Novartis Investigative Site
Maywood, Illinois, 60153
Novartis Investigative Site
McKinney, Texas, 75069
Novartis Investigative Site
Memphis, Tennessee, 38104
Novartis Investigative Site
Miami, Florida, 33143
Novartis Investigative Site
Milwaukee, Wisconsin, 53215
Novartis Investigative Site
Minneapolis, Minnesota, 55417
Novartis Investigative Site
Minneapolis, Minnesota, 55433
Novartis Investigative Site
Minneapolis, Minnesota, 55455
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Morristown, New Jersey, 07960
Novartis Investigative Site
Muscle Shoals, Alabama, 35662
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
Nashville, Tennessee, 37212
Novartis Investigative Site
New Brunswick, New Jersey, 08901
Novartis Investigative Site
New Haven, Connecticut, 06520-8062
Novartis Investigative Site
Northport, New York, 11768
Novartis Investigative Site
Northridge, California, 91325
Novartis Investigative Site
Oakbrook Terrace, Illinois, 60181
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Peoria, Illinois, 61602
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107
Novartis Investigative Site
Portland, Maine, 04102
Novartis Investigative Site
Portland, Oregon, 97225
Novartis Investigative Site
Providence, Rhode Island, 02908
Novartis Investigative Site
Quincy, Illinois, 62301
Novartis Investigative Site
Rapid City, South Dakota, 57701
Novartis Investigative Site
Ridgewood, New Jersey, 07450
Novartis Investigative Site
Rochester, New York, 14642
Novartis Investigative Site
Saginaw, Michigan, 48601
Novartis Investigative Site
Saint Cloud, Minnesota, 56303
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Saint Paul, Minnesota, 55102
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Salt Lake City, Utah, 84124
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Salt Lake City, Utah, 84132
Novartis Investigative Site
San Antonio, Texas, 78234
Novartis Investigative Site
San Diego, California, 92161
Novartis Investigative Site
Santa Ana, California, 92704
Novartis Investigative Site
Saratoga Springs, New York, 12866
Novartis Investigative Site
Seattle, Washington, 98122
Novartis Investigative Site
Seattle, Washington, 98195
Novartis Investigative Site
Sioux Falls, South Dakota, 57104
Novartis Investigative Site
Slidell, Louisiana, 70458
Novartis Investigative Site
St Louis, Missouri, 63110
Novartis Investigative Site
St Louis, Missouri, 63136
Novartis Investigative Site
Stamford, Connecticut, 06905
Novartis Investigative Site
Tallahassee, Florida, 32308
Novartis Investigative Site
The Bronx, New York, 10467
Novartis Investigative Site
Tomball, Texas, 77375
Novartis Investigative Site
Tulsa, Oklahoma, 74133
Novartis Investigative Site
Warwick, Rhode Island, 02886
Novartis Investigative Site
West Haven, Connecticut, 06516
Novartis Investigative Site
White River Junction, Vermont, 05009
Novartis Investigative Site
Winston-Salem, North Carolina, 27157
Novartis Investigative Site
Yardley, Pennsylvania, 19067
Germany64 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Bad Homburg, 61348
Novartis Investigative Site
Bad Krozingen, 79189
Novartis Investigative Site
Bamberg, 96049
Novartis Investigative Site
Berlin, 10789
Novartis Investigative Site
Berlin, 12157
Novartis Investigative Site
Berlin, 12683
Novartis Investigative Site
Berlin, 13086
Novartis Investigative Site
Berlin, 13353
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Berlin, 13405
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Buch, 13125
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Chemnitz, 09126
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Chemnitz, 09130
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Cologne, 51065
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Dessau, 06846
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Dresden, Saxony, 01099
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Dresden, 01277
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Dresden, 01307
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Dresden, 01309
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Duisburg, 47137
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Eilenburg, D 04838
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Elsterwerda, 04910
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Essen, 45355
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Frankfurt, 60594
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Frankfurt, 65929
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Hamburg, 20099
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Hamburg, 20246
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Hamburg, 22041
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Hamburg, 22765
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Haßloch, 67454
Novartis Investigative Site
Heidenau, 01809
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Heppenheim an der Bergstrasse, 64646
Novartis Investigative Site
Homburg, 66421
Novartis Investigative Site
Ingelheim, 55218
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Jena, 07740
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Kassel, 34121
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Kleve, 47533
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Koblenz, 56068
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Leipzig, 04103
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Löhne, 32584
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Ludwigshafen, 67071
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Lüneburg, 21339
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Mainz, 55116
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Meißen, 01662
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Memmingen, 87700
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Muehldorf Am Inn, 84453
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Mühldorf, 84453
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München, 81675
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Munich, 80638
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Münster, 48149
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Nienburg, 31582
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Northeim, 37154
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Oschatz, 04758
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Papenburg, 26871
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Reinfeld, 23858
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Riesa, 01589
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Rodgau, 63110
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Siegen, 57072
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Ulm, 89077
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Wermsdorf, 04779
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Weyhe, 28844
Novartis Investigative Site
Witten, 58455
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Wittenberg, 06886
Novartis Investigative Site
Würzburg, 97080
China39 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100037
Novartis Investigative Site
Beijing, Beijing Municipality, 100039
Novartis Investigative Site
Beijing, Beijing Municipality, 100044
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
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Beijing, 100029
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Beijing, 100034
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Changchun, Jilin, 130022
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Changsha, Hunan, 410003
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Chengdu, Sichuan, 610041
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Chongqing, Chongqing Municipality, 400010
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Chongqing, 400037
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Guangzhou, Guangdong, 51000
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Guangzhou, Guangdong, 510080
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Guangzhou, Guangdong, 510515
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Hangzhou, Zhejiang, 310009
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Hangzhou, Zhejiang, 310013
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Hangzhou, Zhejiang, 310016
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Jilin City, Jilin, 132000
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Jinan, 250012
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Lanzhou, Gansu, 730030
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Nanchang, Jiangxi, 330006
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Nanjing, Jiangsu, 210009
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Nanjing, Jiangsu, 210029
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Nanjing, 210036
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Nanning, Guangxi, 530021
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Shanghai, Shanghai Municipality, 200032
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Shanghai, Shanghai Municipality, 200120
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Shanghai, Shanghai Municipality
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Shanghai, 200025
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Shanghai, 200031
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Shanghai, 200080
Novartis Investigative Site
Shenyang, Liaoning, 110003
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Shenyang, Liaoning, 110016
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Suzhou, Jiangsu, 215004
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Tianjin, Tianjin Municipality, 300121
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Ürümqi, Xinjiang, 830054
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Wuxi, Jiangsu
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Xi’an, Shanxi, 710032
Novartis Investigative Site
Xian, Shanxi, 710061
Spain31 sites
Novartis Investigative Site
A Coruña, Galicia, 15006
Novartis Investigative Site
Almería, Andalusia, 04120
Novartis Investigative Site
Alzira, Valencia, 46600
Novartis Investigative Site
Aranda de Duero, Castille and León, 09400
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Badalona, Catalonia, 08916
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Barcelona, Catalonia, 08003
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Ciudad Real, 13005
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Córdoba, Andalusia, 14004
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El Palmar, Murcia, 30120
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León, Castille and León, 24071
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Lleida, Catalonia, 25198
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28046
Novartis Investigative Site
Madrid, 28222
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Málaga, Andalusia, 29010
Novartis Investigative Site
Marbella, Andalusia, 29600
Novartis Investigative Site
Mérida, Extremadura, 06800
Novartis Investigative Site
Móstoles, Madrid, 28935
Novartis Investigative Site
Olot, Girona, 17800
Novartis Investigative Site
Sanlúcar de Barrameda, Andalusia, 11540
Novartis Investigative Site
Sant Joan Despí, Barcelona, 08970
Novartis Investigative Site
Santander, Cantabria, 39008
Novartis Investigative Site
Santiago de Compostela, Galicia, 15706
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Seville, Andalusia, 41013
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Seville, Andalusia, 41014
Novartis Investigative Site
Valencia, Valencia, 46010
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Valencia, Valencia, 46014
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Valencia, Valencia, 46026
Novartis Investigative Site
Villamartín, Cadiz, 11650
United Kingdom30 sites
Novartis Investigative Site
Basingstoke, Hampshire, RG24 9NA
Novartis Investigative Site
Cheshire, CW1 4QJ
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Clydebank, West Dumbartonshire, G81 4HX
Novartis Investigative Site
Coventry, CV2 2DX
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Darlington, Co Durham, DL3 8SQ
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Dorchester, Dorset, DT1 2JY
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Dundee, DD1 9SY
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Durham, County Durham, DH1 5TW
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Gateshead, Tyne and Wear, NE9 6SX
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Glasgow, Scotland, G12 8TA
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Glasgow, G20 0XA
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Harrow, Middlesex, HA1 3UJ
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High Wycombe, Buckinghamshire, HP11 2TT
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Hull, HU16 5JQ
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London, SE5 9RS
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London, SW 6NP
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Newport, NP20 2UB
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Nottingham, NG5 1PB
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Oldham, Lancashire, OL1 2JH
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Peterborough, GBR, PE3 6DA
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Portadown, Nothern Ireland, BT63 5QQ
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Portsmouth, Hampshire, PO6 3LY
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Sheffield, S5 7AU
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Stockton-on-Tees, Cleveland, TS19 8PE
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Swindon, SN3 6BB
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Taunton, Somerset, TA1 5DA
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Torquay, Devon, TQ2 7AA
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Wansford, Peterborough, PE8 6PL
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Wiltshire, SN15 2SB
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Wrexham, LL13 7TD
Russia29 sites
Novartis Investigative Site
Ivanovo, 153012
Novartis Investigative Site
Izhevsk, 426009
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Izhevsk, 426063
Novartis Investigative Site
Kemerovo, 650029
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Kemerovo, 650099
Novartis Investigative Site
Kirov, 610027
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Kirov, 610035
Novartis Investigative Site
Moscow, 101990
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Moscow, 117198
Novartis Investigative Site
Moscow, 121309
Novartis Investigative Site
Moscow, 121552
Novartis Investigative Site
N.Novgorod, 603005
Novartis Investigative Site
Perm, 614990
Novartis Investigative Site
Rostov-on-Don, 344022
Novartis Investigative Site
Rostov-on-Don, 344068
Novartis Investigative Site
Saint Petersburg, 192257
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Saint Petersburg, 194044
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Saint Petersburg, 194295
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Saint Petersburg, 196601
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Saint Petersburg, 197022
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Saint Petersburg, 197110
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Saint Petersburg, 197341
Novartis Investigative Site
Saint Petersburg, 199106
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Saratov, 410012
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Sestroretsk, 197706
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Smolensk, 214018
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Yaroslavl, 150003
Novartis Investigative Site
Yekaterinburg, 620028
Novartis Investigative Site
Yekaterinburg, 620137
Italy28 sites
Novartis Investigative Site
Aosta, AO, 11100
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Ariccia, RM, 00041
Novartis Investigative Site
Bergamo, BG, 24127
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Bologna, BO, 40138
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Brescia, BS, 25123
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Cona, FE, 44100
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Cortona, AR, 52044
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Messina, ME, 98125
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Milan, MI, 20162
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Milan, 20149
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Monza, MB, 20900
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Naples, 80131
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Padova, PD, 35128
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Palmanova, UD, 33057
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Pavia, PV, 27100
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Perugia, PG, 06100
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Perugia, PG, 06129
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Pozzilli, IS, 86077
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Roma, RM, 00163
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Roma, RM, 00189
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San Daniele del Friuli, UD, 33038
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Saronno, Va, 21047
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Sassari, SS, 07100
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Treviglio, BG, 24047
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Trieste, TS, 34142
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Trieste, TS, 34149
Novartis Investigative Site
Venezia, VE, 30174
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Vimercate, MI, 200059
Slovakia26 sites
Novartis Investigative Site
Bardejov, 085 01
Novartis Investigative Site
Bratislava, 821 07
Novartis Investigative Site
Bratislava, 831 01
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Bratislava, 833 48
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Bratislava, 841 07
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Bratislava, 842 31
Novartis Investigative Site
Bratislava, 851 01
Novartis Investigative Site
Brezno, Slovak Republic, 977 42
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Komárno, Slovak Republic, 94501
Novartis Investigative Site
Košice, 040 01
Novartis Investigative Site
Levice, Slovak Republic, 93401
Novartis Investigative Site
Levice, 934 01
Novartis Investigative Site
Lučenec, 984 01
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Lučenec, 98439
Novartis Investigative Site
Námestovo, Slovak Republic, 02901
Novartis Investigative Site
Nitra, 949 01
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Nitra, 949 88
Novartis Investigative Site
Nové Zámky, 940 01
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Nové Zámky, 94002
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Piešťany, 921 01
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Považská Bystrica, Slovak Republic, 01701
Novartis Investigative Site
Prešov, Slovak Republic, 08001
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Prešov, 080 01
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Svidník, 089 01
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Trebišov, 075 01
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Žilina, 012 07
Argentina25 sites
Novartis Investigative Site
Buenos Aires, C1425AGP
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Buenos Aires, C1428DCO
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Caba, Buenos Aires, C1280AEB
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CABA, Buenos Aires, 1407
Novartis Investigative Site
CABA, Buenos Aires, C1056ABJ
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CABA, Buenos Aires F.D., C1179AAB
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CABA, C1119ACN
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Córdoba, X5000AAX
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Córdoba, X5000EVQ
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Córdoba, X5009BSN
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Córdoba, X5016KET
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Córdoba, X5022CPU
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Formosa, P3600
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Posadas, Misiones Province, N3300AHX
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Quilmes, Buenos Aires, B1878GEG
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Ramos Mejía, Buenos Aires, B1704ETD
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Rosario, Santa Fe Province, 2000
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Rosario, Santa Fe Province, 3080
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Rosario, Santa Fe Province, S2000DSV
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Rosario, Santa Fe Province, S2000QID
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Salta, Salta Province, A4406BPF
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San Luis, D5702JRS
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL
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San Miguel de Tucumán, Tucumán Province, T4000IFL
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Santa Fe, S3000FWO
Czechia21 sites
Novartis Investigative Site
Brandýs nad Labem, Czech Republic, 250 01
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Brno, Czech Republic, 60200
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CZE, 11000
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Ivančice, Czech Republic, 66491
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Kladno, Czech Republic, 272 80
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Kolín, 280 20
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Liberec, Czech Republic, 460 05
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Louny, Czech Republic
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Mariánské Lázně, 353 01
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Ostrava, Czech Republic, 70200
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Pilsen, Czech Republic, 30100
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Policska, CZE, 57201
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Prague, Czech Republic, 140 21
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Prague, CZE, 128 08
Novartis Investigative Site
Rožnov pod Radhoštěm, Czech Republic, 756 61
Novartis Investigative Site
Svitavy, Czech Republic, 568 25
Novartis Investigative Site
Třebíč, Czech Republic, 674 01
Novartis Investigative Site
Uherské Hradiště, 68601
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Ústí nad Labem, Czech Republic, 400 01
Novartis Investigative Site
Ústí nad Labem, CZE, 400 01
Novartis Investigative Site
Znojmo, Czech Republic, 66902
Bulgaria19 sites
Novartis Investigative Site
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About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
Read the detailed description
This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.
For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.
- Being tested
- LCZ696, Valsartan
- Keywords
- Heart failure, preserved ejection fraction, diastolic heart failure
- Medical subject headings
- Heart Failure, Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCZ696Drug
LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.
ValsartanDrug
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
| Study group | Role | What they receive |
|---|---|---|
| LCZ696 | Experimental | Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d. Receives: Drug: LCZ696 |
| Valsartan | Active comparator | Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d. Receives: Drug: Valsartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.
Measured: Total follow up time (up to 57 months)
Secondary outcomes (4)
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure (HF) patients. The clinical summary score, which is derived from the physical limitations and heart failure (HF) symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. Evaluation of change from baseline to month 8 in KCCQ a most sensitive, specific, and responsive health-related quality of life measure for heart failure symptoms and physical limitations.
Measured: Baseline, 8 months
Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading scale used to classify a heart failure's (HF) patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.
Measured: Baseline, 8 months
Participants With First Occurrence of a Composite Renal Endpoint
Analyis of composite renal endpoint defined as renal death, or reaching ESRD, or ≥50% decline in eGFR relative to baseline, using Cox's proportional hazards model.
Measured: Randomization to total follow-up time (up to 57 months)
All-cause Mortality
Analysis for all-cause mortality using Cox's proportional hazards model.
Measured: Randomization to total follow up time (up to 57 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study start18 Jul 2014
- Primary completion7 Jun 2019
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920711
- Sponsor's protocol ID
- CLCZ696D2301
- Other IDs
- 2013-001747-31
- Acronym
- PARAGON-HF
- Status last verified
- Sep 2020
- First submitted
- 8 Aug 2013
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Publications
Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.
PubMed 42669134Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.
PubMed 40839760Lu H, Claggett BL, Minamisawa M, Ostrominski JW, Foa A, Pabon MA, Kalayci A, Vaduganathan M, Cikes M, Shah AM, Desai AS, McMurray JJV, Jhund PS, Packer M, Lefkowitz M, Rouleau JL, Zile MR, Zannad F, Hegde SM, Solomon SD, Skali H. Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON-HF Trial. J Am Heart Assoc. 2025 May 6;14(9):e038872. doi: 10.1161/JAHA.124.038872. Epub 2025 Apr 23.
PubMed 40265602Kondo T, Jhund PS, Anand IS, Claggett BL, Desai AS, Docherty KF, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez FA, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF. JACC Heart Fail. 2025 Jun;13(6):927-939. doi: 10.1016/j.jchf.2024.12.010. Epub 2025 Mar 12.
PubMed 40088233Peikert A, Vaduganathan M, Claggett BL, Kulac IJ, Litwin S, Zile M, Desai AS, Jhund PS, Butt JH, Lam CSP, Martinez F, Van Veldhuisen DJ, Zannad F, Rouleau J, Lefkowitz M, McMurray JJV, Solomon SD, Packer M. Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial. Eur Heart J. 2025 Jul 1;46(25):2372-2390. doi: 10.1093/eurheartj/ehaf057.
PubMed 39873282Mc Causland FR, Vaduganathan M, Claggett B, Gori M, Jhund PS, McGrath MM, Neuen BL, Packer M, Pfeffer MA, Rouleau JL, Senni M, Swedberg K, Zannad F, Zile M, Lefkowitz MP, McMurray JJV, Solomon SD. Angiotensin Receptor Neprilysin Inhibition and Cardiovascular Outcomes Across the Kidney Function Spectrum: The PARAGON-HF Trial. JACC Heart Fail. 2025 Jan;13(1):105-114. doi: 10.1016/j.jchf.2024.08.022. Epub 2024 Nov 20.
PubMed 39570234Lu H, Claggett BL, Packer M, Pfeffer MA, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Visit-to-visit changes in heart rate in heart failure: A pooled participant-level analysis of the PARADIGM-HF and PARAGON-HF trials. Eur J Heart Fail. 2025 Jan;27(1):60-68. doi: 10.1002/ejhf.3487. Epub 2024 Oct 22.
PubMed 39439294Lu H, Claggett BL, Packer M, Pabon MA, Pfeffer MA, Lewis EF, Lam CSP, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Race in Heart Failure: A Pooled Participant-Level Analysis of the Global PARADIGM-HF and PARAGON-HF Trials. JACC Heart Fail. 2025 Jan;13(1):58-71. doi: 10.1016/j.jchf.2024.08.008. Epub 2024 Aug 31.
PubMed 39387766Lu H, Claggett BL, Packer M, Pfeffer MA, Lam CSP, Zile MR, Desai AS, Jhund P, Lefkowitz M, McMurray JJV, Solomon SD, Vaduganathan M. Sacubitril/valsartan reduces incident anaemia and iron therapy utilization in heart failure: The PARAGON-HF trial. Eur J Heart Fail. 2025 Jan;27(1):85-95. doi: 10.1002/ejhf.3414. Epub 2024 Sep 1.
PubMed 39217577Lu H, Chatur S, Lee S, Inciardi RM, Abanda M, Mc Causland FR, Kalayci A, Taheri KK, Shah AM, Cikes M, Claggett BL, Prasad N, Lam CSP, O'Meara E, Wang X, McMurray JJV, Pfeffer MA, Hegde SM, Solomon SD, Skali H. Relationship Between Cardiac Structure and Function With Renal Function Trajectory and Outcomes in Patients With Heart Failure: Insights From the PARAGON-HF Trial. Circ Heart Fail. 2024 Oct;17(10):e011942. doi: 10.1161/CIRCHEARTFAILURE.124.011942. Epub 2024 Aug 30.
PubMed 39212045Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
PubMed 39210725Yoon M, Kim W, Kook W, Park JJ, Greenberg B. Analysis of the PARAGON-HF Study Results Using Win Ratio. Circ Heart Fail. 2024 Sep;17(9):e011860. doi: 10.1161/CIRCHEARTFAILURE.124.011860. Epub 2024 Aug 28.
PubMed 39193709Lassen MCH, Ostrominski JW, Claggett BL, Packer M, Zile M, Desai AS, Shah AM, Cikes M, Merkely B, Gori M, Wang X, Hegde SM, Pfeffer MA, Lefkowitz M, McMurray JJV, Solomon SD, Vaduganathan M. Cardiovascular-kidney-metabolic overlap in heart failure with preserved ejection fraction: Cardiac structure and function, clinical outcomes, and response to sacubitril/valsartan in PARAGON-HF. Eur J Heart Fail. 2024 Aug;26(8):1762-1774. doi: 10.1002/ejhf.3304. Epub 2024 Jun 26.
PubMed 38932589Patel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21.
PubMed 38904251Chatur S, Beldhuis IE, Claggett BL, McCausland FR, Neuen BL, Desai AS, Rouleau JL, Zile MR, Packer M, Pfeffer MA, Lefkowitz MP, McMurray JJV, Solomon SD, Vaduganathan M. Sacubitril/Valsartan in Patients With Heart Failure and Deterioration in eGFR to <30 mL/min/1.73 m2. JACC Heart Fail. 2024 Oct;12(10):1692-1703. doi: 10.1016/j.jchf.2024.03.014. Epub 2024 Jun 5.
PubMed 38842957
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
- ClinicalTrials.gov ID
- NCT01920711
- Acronym / sponsor ID
- PARAGON-HF / CLCZ696D2301
- Keywords
- Heart failure, preserved ejection fraction, diastolic heart failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,822 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2014 (actual)
- Primary completion
- 7 Jun 2019 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
Detailed description
This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication.
For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCZ696 | Experimental | Drug: LCZ696Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d. |
| Valsartan | Active comparator | Drug: ValsartanSingle Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
- Current symptom(s) of HF (NYHA class II-IV)
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- Elevated NT-proBNP
Key exclusion criteria (8 listed)
- Any prior measurement of LVEF < 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
- Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
- Current acute decompensated HF requiring therapy.
- Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCZ696LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments. | Drug | LCZ696 |
| ValsartanValsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments. | Drug | Valsartan |
Primary outcome
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
Time frame: Total follow up time (up to 57 months)
The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association [NYHA] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction [LVEF] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.
4 secondary outcomes
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Baseline, 8 months
Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
Time frame: Baseline, 8 months
Participants With First Occurrence of a Composite Renal Endpoint
Time frame: Randomization to total follow-up time (up to 57 months)
All-cause Mortality
Time frame: Randomization to total follow up time (up to 57 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42669134Lu H, Claggett BL, Ostrominski JW, Pfeffer MA, Pitt B, Jhund PS, McMurray JJV, Solomon SD, Desai AS, Vaduganathan M. Time in blood pressure range and cardiovascular outcomes in HFmrEF/HFpEF: a pooled participant-level analysis of four large-scale trials. Eur J Heart Fail. 2026 Aug 30:xuag245. doi: 10.1093/ejhf/xuag245. Online ahead of print.
- Derived from this study: PubMed 40839760Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.
- Derived from this study: PubMed 40265602Lu H, Claggett BL, Minamisawa M, Ostrominski JW, Foa A, Pabon MA, Kalayci A, Vaduganathan M, Cikes M, Shah AM, Desai AS, McMurray JJV, Jhund PS, Packer M, Lefkowitz M, Rouleau JL, Zile MR, Zannad F, Hegde SM, Solomon SD, Skali H. Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON-HF Trial. J Am Heart Assoc. 2025 May 6;14(9):e038872. doi: 10.1161/JAHA.124.038872. Epub 2025 Apr 23.
- Derived from this study: PubMed 40088233Kondo T, Jhund PS, Anand IS, Claggett BL, Desai AS, Docherty KF, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez FA, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF. JACC Heart Fail. 2025 Jun;13(6):927-939. doi: 10.1016/j.jchf.2024.12.010. Epub 2025 Mar 12.
- Derived from this study: PubMed 39873282Peikert A, Vaduganathan M, Claggett BL, Kulac IJ, Litwin S, Zile M, Desai AS, Jhund PS, Butt JH, Lam CSP, Martinez F, Van Veldhuisen DJ, Zannad F, Rouleau J, Lefkowitz M, McMurray JJV, Solomon SD, Packer M. Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial. Eur Heart J. 2025 Jul 1;46(25):2372-2390. doi: 10.1093/eurheartj/ehaf057.
- Derived from this study: PubMed 39570234Mc Causland FR, Vaduganathan M, Claggett B, Gori M, Jhund PS, McGrath MM, Neuen BL, Packer M, Pfeffer MA, Rouleau JL, Senni M, Swedberg K, Zannad F, Zile M, Lefkowitz MP, McMurray JJV, Solomon SD. Angiotensin Receptor Neprilysin Inhibition and Cardiovascular Outcomes Across the Kidney Function Spectrum: The PARAGON-HF Trial. JACC Heart Fail. 2025 Jan;13(1):105-114. doi: 10.1016/j.jchf.2024.08.022. Epub 2024 Nov 20.
- Derived from this study: PubMed 39439294Lu H, Claggett BL, Packer M, Pfeffer MA, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Visit-to-visit changes in heart rate in heart failure: A pooled participant-level analysis of the PARADIGM-HF and PARAGON-HF trials. Eur J Heart Fail. 2025 Jan;27(1):60-68. doi: 10.1002/ejhf.3487. Epub 2024 Oct 22.
- Derived from this study: PubMed 39387766Lu H, Claggett BL, Packer M, Pabon MA, Pfeffer MA, Lewis EF, Lam CSP, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Race in Heart Failure: A Pooled Participant-Level Analysis of the Global PARADIGM-HF and PARAGON-HF Trials. JACC Heart Fail. 2025 Jan;13(1):58-71. doi: 10.1016/j.jchf.2024.08.008. Epub 2024 Aug 31.
- Derived from this study: PubMed 39217577Lu H, Claggett BL, Packer M, Pfeffer MA, Lam CSP, Zile MR, Desai AS, Jhund P, Lefkowitz M, McMurray JJV, Solomon SD, Vaduganathan M. Sacubitril/valsartan reduces incident anaemia and iron therapy utilization in heart failure: The PARAGON-HF trial. Eur J Heart Fail. 2025 Jan;27(1):85-95. doi: 10.1002/ejhf.3414. Epub 2024 Sep 1.
- Derived from this study: PubMed 39212045Lu H, Chatur S, Lee S, Inciardi RM, Abanda M, Mc Causland FR, Kalayci A, Taheri KK, Shah AM, Cikes M, Claggett BL, Prasad N, Lam CSP, O'Meara E, Wang X, McMurray JJV, Pfeffer MA, Hegde SM, Solomon SD, Skali H. Relationship Between Cardiac Structure and Function With Renal Function Trajectory and Outcomes in Patients With Heart Failure: Insights From the PARAGON-HF Trial. Circ Heart Fail. 2024 Oct;17(10):e011942. doi: 10.1161/CIRCHEARTFAILURE.124.011942. Epub 2024 Aug 30.
- Derived from this study: PubMed 39210725Lu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
- Derived from this study: PubMed 39193709Yoon M, Kim W, Kook W, Park JJ, Greenberg B. Analysis of the PARAGON-HF Study Results Using Win Ratio. Circ Heart Fail. 2024 Sep;17(9):e011860. doi: 10.1161/CIRCHEARTFAILURE.124.011860. Epub 2024 Aug 28.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
715 sites in 43 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LCZ696 and Valsartan in people with Heart Failure With Preserved Ejection Fraction, run by Novartis Pharmaceuticals at 715 sites in 43 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 715 sites in United States, Germany, China, Spain, United Kingdom and 38 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations. (time frame: Total follow up time (up to 57 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920711, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.