AzTrials
AzTrials

Heart Failure With Preserved Ejection FractionPhase 3PARALLAXNCT03066804

A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

A Phase 3 study testing sacubitril/valsartan, Enalapril and Valsartan in people with Heart Failure With Preserved Ejection Fraction, run by Novartis Pharmaceuticals at 380 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF). Read more about this study

Who is it for?
Ages 45 years and older
What is being tested?
sacubitril/valsartan, Enalapril and Valsartan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,572 participants
Where
380 sitesin 32 countries
Study dates
22 Aug 2017to 28 Oct 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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Left ventricular ejection fraction (LVEF) >40% by echo within 6 months prior to study entry or during the screening epoch
  • Symptom(s) of heart failure (HF) requiring treatment with diuretics (including loop, or thiazide diuretics, or mineralocorticoid antagonist [MRAs]) for at least 30 days prior to study entry
  • NYHA class II-IV
  • Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
  • NT-proBNP > 220 pg/mL for patients with no atrial fibrillation/atrial flutter (AF) or >600 pg/mL for patients with AF
  • KCCQ clinical summary score < 75
  • Patients on ACEi or ARB therapy must have a history of HTN

Who cannot join

  • Any prior measurement of LVEF ≤ 40%, under stable conditions
  • Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention (PCI) within 3 months or an elective PCI within 30 days prior to study entry
  • Any clinical event within the 6 months prior to Visit 1 that could have reduced the LVEF (eg MI, coronary artery bypass graft [CABG]), unless an echo measurement was performed after the event confirming the LVEF to be >40%
  • Current (within 30 days from Visit 1) acute decompensated HF requiring therapy.
  • Current (within 30 days from Visit 1) use of renin inhibitor(s), dual RAS blockade or LCZ696
  • History of hypersensitivity to LCZ696 or its components
Show all 17Show fewer
  • Patients with a known history of angioedema
  • Walk distance primarily limited by non-cardiac comorbid conditions at study entry
  • Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dL males and < 9.5 g/dL females, or body mass index (BMI) > 40 kg/m^2.
  • Systolic blood pressure (SBP) ≥ 180 mmHg at study entry, or SBP >150 mmHg and <180 mmHg at study entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at study entry.
  • Patients with HbA1c > 7.5% not treated for diabetes
  • Patients with prior major organ transplant or intent to transplant (ie on transplant list)
  • eGFR < 30 ml/min/1.73 m^2 as measured by MDRD at screening
  • Serum potassium > 5.2 mmol /L (or equivalent plasma potassium value) at study entry
  • History or presence of any other disease with a life expectancy of < 3 years
  • Pregnant or nursing women or women of child-bearing potential unless they are using highly effective methods of contraception
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

380 sites in 32 countries.

380 sites in 32 countries

Germany68 sites

  • Novartis Investigative Site

    Bad Homburg, 61348

  • Novartis Investigative Site

    Bad Oeynhausen, 32545

  • Novartis Investigative Site

    Bamberg, 96049

  • Novartis Investigative Site

    Berlin, 10787

  • Novartis Investigative Site

    Berlin, 10789

  • Novartis Investigative Site

    Berlin, 12157

  • Novartis Investigative Site

    Berlin, 12683

  • Novartis Investigative Site

    Berlin, 13347

  • Novartis Investigative Site

    Berlin, 13353

  • Novartis Investigative Site

    Berlin, D 10559

  • Novartis Investigative Site

    Bielefeld, 33604

  • Novartis Investigative Site

    Brüel, 19412

  • Novartis Investigative Site

    Buch, 13125

  • Novartis Investigative Site

    Chemnitz, 09130

  • Novartis Investigative Site

    Coburg, 96450

  • Novartis Investigative Site

    Cologne, D-51065

  • Novartis Investigative Site

    Detmold, North Rhine-Westphalia, 32756

  • Novartis Investigative Site

    Dortmund, 44137

  • Novartis Investigative Site

    Dortmund, 44379

  • Novartis Investigative Site

    Dresden, Saxony, 01099

  • Novartis Investigative Site

    Dresden, 01069

  • Novartis Investigative Site

    Dresden, 01277

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Elsterwerda, 04910

  • Novartis Investigative Site

    Erfurt, 99097

  • Novartis Investigative Site

    Essen, DEU, 45138

  • Novartis Investigative Site

    Essen, 45277

  • Novartis Investigative Site

    Frankfurt, 60594

  • Novartis Investigative Site

    Frankfurt, 65929

  • Novartis Investigative Site

    Fulda, 36037

  • Novartis Investigative Site

    Fürth, 90766

  • Novartis Investigative Site

    Halle, 06120

  • Novartis Investigative Site

    Hamburg, 21075

  • Novartis Investigative Site

    Haßloch, 67454

  • Novartis Investigative Site

    Jena, 07740

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Koeln-Nippes, 50733

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Lübeck, 23538

  • Novartis Investigative Site

    Ludwigshafen, 67067

  • Novartis Investigative Site

    Ludwigshafen, 67071

  • Novartis Investigative Site

    Lüneburg, 21339

  • Novartis Investigative Site

    Mainz, 55116

  • Novartis Investigative Site

    Mannheim, 68165

  • Novartis Investigative Site

    Mühldorf, 84453

  • Novartis Investigative Site

    Munich, 80638

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Neuruppin, 16816

  • Novartis Investigative Site

    Nienburg, 31582

  • Novartis Investigative Site

    Nuremberg, 90402

  • Novartis Investigative Site

    Papenburg, 26871

  • Novartis Investigative Site

    Potsdam, 14471

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Riesa, 01589

  • Novartis Investigative Site

    Rodgau, 63110

  • Novartis Investigative Site

    Rostock, 18107

  • Novartis Investigative Site

    Rotenburg an der Fulda, 36199

  • Novartis Investigative Site

    Rüsselsheim am Main, 65428

  • Novartis Investigative Site

    Schwäbisch Hall, 74523

  • Novartis Investigative Site

    Siegen, 57072

  • Novartis Investigative Site

    Stadtlohn, 48703

  • Novartis Investigative Site

    Ulm, 89077

  • Novartis Investigative Site

    Ulm, 89081

  • Novartis Investigative Site

    Wallerfing, 94574

  • Novartis Investigative Site

    Wattenscheid, 44866

  • Novartis Investigative Site

    Wedel, 22880

  • Novartis Investigative Site

    Wismar, 23966

  • Novartis Investigative Site

    Würzburg, 97080

Other trials in Germany

United States32 sites

  • Novartis Investigative Site

    Abington, Pennsylvania, 19001

  • Novartis Investigative Site

    Alexandria, Louisiana, 71301

  • Novartis Investigative Site

    Andalusia, Alabama, 36420

  • Novartis Investigative Site

    Arlington Heights, Illinois, 60004

  • Novartis Investigative Site

    Aurora, Colorado, 80045

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Novartis Investigative Site

    Boston, Massachusetts, 02114

  • Novartis Investigative Site

    Bradenton, Florida, 34209

  • Novartis Investigative Site

    Chalmette, Louisiana, 70043

  • Novartis Investigative Site

    Corvallis, Oregon, 97330

  • Novartis Investigative Site

    Dallas, Texas, 75234

  • Novartis Investigative Site

    Falls Church, Virginia, 22042

  • Novartis Investigative Site

    Gainesville, Florida, 32608

  • Novartis Investigative Site

    Hollywood, Florida, 33312

  • Novartis Investigative Site

    Houma, Louisiana, 70360

  • Novartis Investigative Site

    Jackson, Tennessee, 38301

  • Novartis Investigative Site

    Lincoln, Nebraska, 68526

  • Novartis Investigative Site

    Long Beach, California, 90813

  • Novartis Investigative Site

    Lufkin, Texas, 75904

  • Novartis Investigative Site

    Marion, Ohio, 43302

  • Novartis Investigative Site

    Miami, Florida, 33133

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Rochester, New York, 14621

  • Novartis Investigative Site

    Santa Ana, California, 92704

  • Novartis Investigative Site

    Seattle, Washington, 98122

  • Novartis Investigative Site

    Sioux Falls, South Dakota, 57104

  • Novartis Investigative Site

    Stamford, Connecticut, 06905

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    Thomasville, Georgia, 31792

  • Novartis Investigative Site

    Tomball, Texas, 77375

Other trials in United States

Russia21 sites

  • Novartis Investigative Site

    Gatchina, 188300

  • Novartis Investigative Site

    Ivanovo, 153012

  • Novartis Investigative Site

    Moscow, 101953

  • Novartis Investigative Site

    Moscow, 117292

  • Novartis Investigative Site

    Moscow, 117556

  • Novartis Investigative Site

    Moscow, 121309

  • Novartis Investigative Site

    Moscow, 129301

  • Novartis Investigative Site

    Nizhny Novgorod, 603126

  • Novartis Investigative Site

    Perm, 614097

  • Novartis Investigative Site

    Rostov-on-Don, 344022

  • Novartis Investigative Site

    Rostov-on-Don, 344068

  • Novartis Investigative Site

    Saint Petersburg, 191015

  • Novartis Investigative Site

    Saint Petersburg, 191144

  • Novartis Investigative Site

    Saint Petersburg, 196601

  • Novartis Investigative Site

    Saint Petersburg, 197376

  • Novartis Investigative Site

    Saint Petersburg, 199106

  • Novartis Investigative Site

    Saratov, 410012

  • Novartis Investigative Site

    Tyumen, 625026

  • Novartis Investigative Site

    Yaroslavl, 150047

  • Novartis Investigative Site

    Yekaterinburg, 620028

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

Slovakia20 sites

  • Novartis Investigative Site

    Bardejov, 085 01

  • Novartis Investigative Site

    Bardejov, 08501

  • Novartis Investigative Site

    Bratislava, SVK, 81108

  • Novartis Investigative Site

    Bratislava, 821 07

  • Novartis Investigative Site

    Bratislava, 842 31

  • Novartis Investigative Site

    Dolný Kubín, 026 01

  • Novartis Investigative Site

    Handlová, SVK, 97251

  • Novartis Investigative Site

    Košice, 040 01

  • Novartis Investigative Site

    Lučenec, 98439

  • Novartis Investigative Site

    Moldava nad Bodvou, 045 01

  • Novartis Investigative Site

    Námestovo, Slovak Republic, 02901

  • Novartis Investigative Site

    Nitra, 949 01

  • Novartis Investigative Site

    Nové Zámky, 940 01

  • Novartis Investigative Site

    Nové Zámky, 94002

  • Novartis Investigative Site

    Považská Bystrica, 01701

  • Novartis Investigative Site

    Prešov, Slovak Republic, 080 01

  • Novartis Investigative Site

    Prešov, 08001

  • Novartis Investigative Site

    Snina, 09601

  • Novartis Investigative Site

    Svidník, 089 01

  • Novartis Investigative Site

    Trnava, 91701

Other trials in Slovakia

Argentina18 sites

  • Novartis Investigative Site

    Buenos Aires, C1430EGF

  • Novartis Investigative Site

    Caba, Buenos Aires, C1280AEB

  • Novartis Investigative Site

    Córdoba, X5000AAW

  • Novartis Investigative Site

    Córdoba, X5000EVQ

  • Novartis Investigative Site

    Córdoba, X5000

  • Novartis Investigative Site

    Córdoba, X5004BAL

  • Novartis Investigative Site

    Córdoba, X5006CBI

  • Novartis Investigative Site

    Formosa, P3600

  • Novartis Investigative Site

    Posadas, Misiones Province, N3300AHX

  • Novartis Investigative Site

    Quilmes, Buenos Aires, B1878GEG

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000DSV

  • Novartis Investigative Site

    Salta, Salta Province, A4406BPF

  • Novartis Investigative Site

    San Luis, D5702JRS

  • Novartis Investigative Site

    San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IFL

  • Novartis Investigative Site

    Santa Fe, 3080

  • Novartis Investigative Site

    Santa Fe, S2200

  • Novartis Investigative Site

    Santa Fe, S3000FWO

Other trials in Argentina

Czechia18 sites

  • Novartis Investigative Site

    Brandýs nad Labem, Czech Republic, 250 01

  • Novartis Investigative Site

    Brno, Czech Republic, 60200

  • Novartis Investigative Site

    Český Krumlov, Czech Republic, 381 01

  • Novartis Investigative Site

    Jablonec nad Nisou, Czech Republic, 466 60

  • Novartis Investigative Site

    Jihlava, CZE, 58633

  • Novartis Investigative Site

    Kolín, 280 20

  • Novartis Investigative Site

    Kroměříž, Czech Republic, 767 55

  • Novartis Investigative Site

    Liberec, Czech Republic, 46063

  • Novartis Investigative Site

    Louny, Czech Republic

  • Novartis Investigative Site

    Olomouc Lazce, 77900

  • Novartis Investigative Site

    Pardubice, Czech Republic, 532 03

  • Novartis Investigative Site

    Pilsen, Czech Republic, 30100

  • Novartis Investigative Site

    Policska, CZE, 57201

  • Novartis Investigative Site

    Přerov, 751 52

  • Novartis Investigative Site

    Svitavy, Czech Republic, 568 25

  • Novartis Investigative Site

    Tábor, Czech Republic, 39003

  • Novartis Investigative Site

    Třebíč, Czech Republic, 674 01

  • Novartis Investigative Site

    Valašské Meziříčí, 75742

Other trials in Czechia

Spain17 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, 03700

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Huelva, Andalusia, 21005

  • Novartis Investigative Site

    Las Palmas de Gran Canarias, 35010

  • Novartis Investigative Site

    Lleida, Catalonia, 25198

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Manises, Valencia, 46940

  • Novartis Investigative Site

    Puerto Real, Cadiz, 11510

  • Novartis Investigative Site

    San Sebastián de los Reyes, Madrid, 28702

  • Novartis Investigative Site

    Seville, 41014

  • Novartis Investigative Site

    Torrevieja (Alicante), Valencia, 03186

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, 46026

  • Novartis Investigative Site

    Villamartín, Cadiz, 11650

Other trials in Spain

Romania15 sites

  • Novartis Investigative Site

    Bacau, 600114

  • Novartis Investigative Site

    Baia Mare, 430123

  • Novartis Investigative Site

    Bucharest, District 4, 4204179

  • Novartis Investigative Site

    Bucharest, 021659

  • Novartis Investigative Site

    Bucharest, 022328

  • Novartis Investigative Site

    Bucharest, 062272

  • Novartis Investigative Site

    Craiova, 200642

  • Novartis Investigative Site

    Craiova, 200931

  • Novartis Investigative Site

    Piteşti, 110084

  • Novartis Investigative Site

    Targoviste, 130095

  • Novartis Investigative Site

    Târgu Mureş, 540142

  • Novartis Investigative Site

    Târgu Mureş, 540143

  • Novartis Investigative Site

    Timișoara, Timiș County, 300041

  • Novartis Investigative Site

    Timișoara, Timiș County, 300362

  • Novartis Investigative Site

    Timișoara, 300736

Other trials in Romania

Turkey (Türkiye)14 sites

  • Novartis Investigative Site

    Adana, 01160

  • Novartis Investigative Site

    Ankara, 06490

  • Novartis Investigative Site

    Antalya, 07070

  • Novartis Investigative Site

    Aydin, 09100

  • Novartis Investigative Site

    Bursa

  • Novartis Investigative Site

    Eskişehir, Meselik, 26480

  • Novartis Investigative Site

    Istanbul, 34304

  • Novartis Investigative Site

    Istanbul, 34662

  • Novartis Investigative Site

    Izmir, 35040

  • Novartis Investigative Site

    Izmir, 35340

  • Novartis Investigative Site

    Kocaeli, 41380

  • Novartis Investigative Site

    Mersin, 33343

  • Novartis Investigative Site

    Sivas, 58140

  • Novartis Investigative Site

    Talas / Kayseri, 38039

Other trials in Turkey (Türkiye)

Brazil13 sites

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30140 062

  • Novartis Investigative Site

    Belo Horizonte, Minas Gerais, 30150-221

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89010 500

  • Novartis Investigative Site

    Campinas, São Paulo, 13060 080

  • Novartis Investigative Site

    Canoas, Rio Grande do Sul, 92425 900

  • Novartis Investigative Site

    Curitiba, Paraná, 80230 130

  • Novartis Investigative Site

    Fortaleza, Ceará, 60430 370

  • Novartis Investigative Site

    Goiânia, Goiás, 74223-130

  • Novartis Investigative Site

    Goiânia, Goiás, 74605 050

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Novartis Investigative Site

    Ribeirão Preto, São Paulo, 14048-900

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15015-750

  • Novartis Investigative Site

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Bulgaria12 sites

  • Novartis Investigative Site

    Burgas, 8018

  • Novartis Investigative Site

    Pazardzhik, 4400

  • Novartis Investigative Site

    Pernik, 2300

  • Novartis Investigative Site

    Pleven, 5800

  • Novartis Investigative Site

    Plovdiv, 4000

  • Novartis Investigative Site

    Plovdiv, 4002

  • Novartis Investigative Site

    Shumen, 9700

  • Novartis Investigative Site

    Sofia, 1233

  • Novartis Investigative Site

    Sofia, 1431

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Italy12 sites

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Cona

  • Novartis Investigative Site

    Cortona, AR, 52044

  • Novartis Investigative Site

    Legnano, MI, 20025

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Rovigo, RO, 45100

  • Novartis Investigative Site

    San Vito al Tagliamento

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Sesto San Giovanni, MI, 20099

Other trials in Italy

India11 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 060

  • Novartis Investigative Site

    Bikaner, Rajasthan, 334003

  • Novartis Investigative Site

    India, 560040

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226003

  • Novartis Investigative Site

    Manipal, Karnataka, 576104

  • Novartis Investigative Site

    Nagpur, Maharashtra, 440009

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005

  • Novartis Investigative Site

    Nashik, Maharashtra, 422007

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110 060

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110007

  • Novartis Investigative Site

    Vadodara, Gujarat, 390022

Other trials in India

Netherlands11 sites

  • Novartis Investigative Site

    Almelo, 7609 PP

  • Novartis Investigative Site

    Amsterdam, 1091AC

  • Novartis Investigative Site

    Deventer, 7416 SE

  • Novartis Investigative Site

    Doetinchem, 7009 BL

  • Novartis Investigative Site

    Gouda, 2803 HH

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Hardenberg, 7770 AA

  • Novartis Investigative Site

    Nijmegen, 6500 HB

  • Novartis Investigative Site

    Stadskanaal, 9501 HE

  • Novartis Investigative Site

    Tilburg, 5022 GC

  • Novartis Investigative Site

    Venlo, 5912 BL

Other trials in Netherlands

France10 sites

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Chambray-lès-Tours, 37170

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Le Coudray, 28630

  • Novartis Investigative Site

    Le Kremlin-Bicêtre, 94275

  • Novartis Investigative Site

    Limoges, 87042

  • Novartis Investigative Site

    Marseille, 13008

  • Novartis Investigative Site

    Rennes, 35033

  • Novartis Investigative Site

    Tourcoing, 59200

  • Novartis Investigative Site

    Valenciennes, 59300

Other trials in France

United Kingdom9 sites

  • Novartis Investigative Site

    Addlestone, Surrey, KT15 2BH

  • Novartis Investigative Site

    Chesterfield, Derbyshire, S44 5BL

  • Novartis Investigative Site

    Craigavon, Northern Ireland, BT63 5QQ

  • Novartis Investigative Site

    High Wycombe, Buckinghamshire, HP11 2TT

  • Novartis Investigative Site

    Leeds, LS1 3EX

  • Novartis Investigative Site

    Stockton-on-Tees, Cleveland, TS19 8PE

  • Novartis Investigative Site

    Sunderland, Tyne and Wear, SR4 7TP

  • Novartis Investigative Site

    Wansford, Peterborough, PE8 6PL

  • Novartis Investigative Site

    York, YO31 8HE

Other trials in United Kingdom

Portugal8 sites

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Lisbon, 1495 005

  • Novartis Investigative Site

    Lisbon, 1500 650

  • Novartis Investigative Site

    Lisbon, 1600190

  • Novartis Investigative Site

    Penafiel, 4564-007

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Viana do Castelo, 4901858

  • Novartis Investigative Site

    Vila Real, 5000-508

Other trials in Portugal

Peru7 sites

  • Novartis Investigative Site

    Callao, CALLAO 2

  • Novartis Investigative Site

    Jesus Maria, Lima region, 11

  • Novartis Investigative Site

    Lima Cercado, Lima region, 01

  • Novartis Investigative Site

    San Borja, Lima region, 41

  • Novartis Investigative Site

    San Isidro, Lima region, 27

  • Novartis Investigative Site

    San Miguel, Lima region, 32

  • Novartis Investigative Site

    Trujillo, La Libertad

Other trials in Peru

Colombia6 sites

  • Novartis Investigative Site

    Barranquilla, 080020

  • Novartis Investigative Site

    Barranquilla

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760001

  • Novartis Investigative Site

    Medellín, Antioquia, 050036

  • Novartis Investigative Site

    Montería

  • Novartis Investigative Site

    San Gil, 684031

Other trials in Colombia

Israel6 sites

  • Novartis Investigative Site

    Ashkelon, 78278

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Hadera

  • Novartis Investigative Site

    Haifa, 310 9601

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    Petah Tikva, 4941492

  • Novartis Investigative Site

    Rehovot, 76100

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Thailand6 sites

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  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

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  • Novartis Investigative Site

    Khon Kaen, THA, 40002

  • Novartis Investigative Site

    Muang, Muang, 65000

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    Hall in Tirol, 6060

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    Linz, 4010

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    Salzburg, 5020

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Belgium5 sites

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    Ghent, 9000

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    Huy, 4500

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    Kortrijk, 8500

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Canada5 sites

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    Hamilton, Ontario, L8L 2X2

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  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

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    Mosanmagyarovar, 9200

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Latvia4 sites

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Mexico4 sites

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About this study

Official title: A 24-week, Randomized, Double-blind, Multi-center, Parallel LCZ696 on NT-proBNP, Exercise Capacity, Symptoms and Safety Compared to Individualized Medical Management of Comorbidities in Patients With Heart Failure and Preserved Ejection Fraction

The purpose of this study is to demonstrate the superiority of LCZ696 over individualized medical therapy for comorbidities in reducing N-terminal pro-brain natriuretic peptide (NT-proBNP) and improving exercise capacity and HF symptoms in patients with heart failure with preserved ejection fraction (HFpEF).

Read the detailed description

This study was a 24-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate sacubitril/valsartan compared to individualized medical therapy on NT proBNP, exercise capacity, symptoms and QoL in patients with heart failure and preserved left ventricular ejection (HFpEF) fraction (LVEF > 40%). Patients were initially stratified into one of three strata according to prior treatment for comorbidities: Angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or no prior renin angiotensin system inhibitors (RASi). Patients in each stratum were randomized in a 1:1 ratio and received either sacubitril/valsartan or comparator (i.e.

enalapril for patients in ACEi strata, valsartan for patients in the ARB strata and placebo for patients in the No RASi strata). There was no designated proportion of patients planned in each stratum; the strata were populated based upon the patient's prior treatment regimen. The study consisted of a screening epoch of up to 2 weeks and a randomized treatment epoch of 24 weeks, which included a 1 to 4 week study drug up-titration epoch followed by a 20 to 23 week maintenance epoch. Uptitration to target doses was recommended to occur within the first four weeks of the study, and was performed by Investigator's discretion based on the patient's clinical status.

Being tested
sacubitril/valsartan, Enalapril, Valsartan, Placebo to match sacubitril/valsartan, Placebo to match enalapril
Keywords
Cardiovascular Diseases, Heart Failure, Heart failure with Preserved Ejection Fraction, NT-proBNP, 6 MWT, KCCQ, SF-36, NYHA Class, LCZ696, Enalapril, Valsartan, Angiotensin-Converting Enzyme Inhibitors (ACEi), Angiotensin II Type 1 Receptor Blockers (ARB), Renin Angiotensin System Inhibitors (RASi)
Medical subject headings
Cardiovascular Diseases, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sacubitril/valsartanDrug

    Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

  • EnalaprilDrug

    Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

  • ValsartanDrug

    Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

  • Placebo to match sacubitril/valsartanDrug

    Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

  • Placebo to match enalaprilDrug

    Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

  • Placebo to match valsartanDrug

    Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Study groups in NCT03066804
Study groupRoleWhat they receive
sacubitril/valsartan (LCZ696)ExperimentalAll patients who fulfill the inclusion/exclusion criteria will be stratified before randomization based upon prior therapy for comorbidities to one of 3 strata: ACEi, ARB or no RASi. Patients in the ACEi strata will receive LCZ696 or enalapril. Patients in the ARB strata will receive LCZ696 or valsartan. Patients in the no RASi strata will receive LCZ696 or matching placebo. Patients in the ACEi and ARB strata will take two pills twice daily for each dose: one tablet from the LCZ696 pack and one tablet from the comparator pack. Patients in the no RASi strata will take only one tablet twice daily (LCZ696 or matching placebo). In the LCZ696 arm, patients will receive active LCZ696 in titrated doses from level 1 up to level 3 (50 mg, 100 mg and 200 mg twice daily orally).
Receives: Drug: sacubitril/valsartan; Drug: Placebo to match enalapril; Drug: Placebo to match valsartan
ComparatorActive comparatorPatients randomized to the comparator arm will receive either enalapril (ACE stratum) valsartan (ARB stratum) or LCZ696 matching placebo (no RASi stratum). Patients in the ACE stratum randomized to comparator, will receive enalapril in titrated doses from level 1 up to level 3 (2.5 mg, 5 mg and 10 mg twice daily). Patients in the ARB stratum randomized to comparator will receive valsartan in titrated doses from level 1 up to level 3 (40 mg , 80 mg and 160 mg twice daily). Patients in the no RASi stratum randomized to comparator will receive LCZ696 matching placebo.
Receives: Drug: Enalapril; Drug: Valsartan; Drug: Placebo to match sacubitril/valsartan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12

    To demonstrate that LCZ696 is superior to individualized medical therapy for comorbidities in reducing NT-proBNP from baseline at Week 12 in patients with HFpEF

    Measured: Baseline, week 12

  2. Change From Baseline in 6 Minute Walk Distance (6MWD) at Week 24

    Change from baseline in 6-minute walk distance (6MWD) will be reported at Week 24. The 6 MWT will be performed in accordance with the guidelines of the American Thoracic Society 2002.

    Measured: Baseline, week 24

Secondary outcomes (5)

  1. Mean Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) at Week 24

    The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

    Measured: Baseline, Week 24

  2. Percentage of Patients With ≥ 5-points Deterioration in KCCQ Clinical Symptom Score(CSS) at Week 24

    Percentage of patients with KCCQ CSS deterioration ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

    Measured: Baseline, Week 24

  3. Percentage of Patients With ≥ 5-points Improvement in KCCQ Clinical Symptom Score(CSS) at Week 24

    Percentage of patients with KCCQ CSS improvement ≥ 5-points will be reported at Week 24. The KCCQ is a self-administered questionnaire that requires 4 to 6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). The CSS is a combined score based upon the clinical symptoms and physical function domains of the questionnaire. Scores are transformed to a range of 0 - 100, in which higher scores reflect better health status.

    Measured: Baseline, Week 24

  4. Change From Baseline in NYHA Functional Class at Week 24

    NYHA classification is a subjective physician's assessment of patient's functional capacity and symptomatic status and can change frequently over time.

    Class I - No limitation of physical activity. Ordinary physical activity does not cause symptoms of HF Class II - Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in symptoms of HF Class III - Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes symptoms of HF Class IV - Unable to carry on any physical activity without symptoms of HF, or symptoms of HF at rest

    The NYHA class change will be analyzed as a three category ordinal variable with levels: "improved", "unchanged", and "worsened", defined by at least one class improvement, no change, at least one class worsening, in NYHA class, respectively.

    Measured: Baseline, week 24

  5. Change From Baseline in The Short Form 36 Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

    The SF-36 PCS score reflects the measure of quality of life based on the 36 questions which evaluate the person's physical, emotional, and mental status, including general health. Specifically, the SF-36 PCS score focuses on assessing the person's physical status. The score ranges from 0 to 100 with a higher score indicating a better status of physical wellbeing (range = 0 "worst"-100 "best").

    Measured: Baseline, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2017
  2. Study start22 Aug 2017
  3. Primary completion28 Oct 2019
  4. Study completion28 Oct 2019

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,572 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03066804
Sponsor's protocol ID
CLCZ696D2302
Other IDs
2016-003410-28, 2016
Acronym
PARALLAX
Status last verified
Oct 2021
First submitted
23 Feb 2017
Last updated
11 Oct 2021
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
Expanded access
Available

Publications

  • Pieske B, Wachter R, Shah SJ, Baldridge A, Szeczoedy P, Ibram G, Shi V, Zhao Z, Cowie MR; PARALLAX Investigators and Committee members. Effect of Sacubitril/Valsartan vs Standard Medical Therapies on Plasma NT-proBNP Concentration and Submaximal Exercise Capacity in Patients With Heart Failure and Preserved Ejection Fraction: The PARALLAX Randomized Clinical Trial. JAMA. 2021 Nov 16;326(19):1919-1929. doi: 10.1001/jama.2021.18463.

    PubMed 34783839

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sacubitril/valsartan, Enalapril and Valsartan in people with Heart Failure With Preserved Ejection Fraction, run by Novartis Pharmaceuticals at 380 sites in 32 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 7 inclusion and 17 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 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 380 sites in Germany, United States, Russia, Slovakia, Argentina and 27 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 8 Feb 2021). 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?

Change From Baseline in N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) at Week 12 (time frame: Baseline, week 12). The study lists 2 primary outcomes in all. 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 NCT03066804, which also lists 1 linked publication.

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 11 Oct 2021.

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