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Heart FailurePhase 4PROVE-HFNCT02887183

Effects of Sacubitril/Valsartan Therapy on Biomarkers, Myocardial Remodeling and Outcomes.

A Phase 4 study testing LCZ696 (sacubitril/valsartan) in people with Heart Failure, run by Novartis Pharmaceuticals at 77 sites in United States.

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

This study was to determine early and more chronic changes in concentrations of biomarkers related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapy over a period of 12 months, and correlated these biomarker changes with cardiac remodeling parameters, patient-reported outcomes and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
LCZ696 (sacubitril/valsartan)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
794 participants
Where
77 sitesUnited States
Study dates
25 Oct 2016to 22 Oct 2018
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Based on the USPI for sacubitril/valsartan, subjects eligible for inclusion in this study must fulfill all of the following criteria at screening and baseline:
  • Written informed consent must be obtained before any assessment is performed.
  • Men and women ≥ 18 years of age.
  • LVEF ≤ 40% subjects who are candidates for on-label sacubitril/valsartan treatment per standard of care.
  • New York Heart Association (NYHA) Functional class II-IV.
  • LVEF ≤40% via any local measurement within the past 6 months using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography provided no subsequent study documenting an EF of >40%. If the EF measurement is expressed as a value range, the average of the range endpoint values should be used as the EF.
  • If a subject is on a loop diuretic, they must be on a stable dose for 2 weeks prior to baseline.

Who cannot join

  • Subjects fulfilling any of the following criteria, at screening and prior to dispensing of study drug, are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects/subjects.
  • pregnant or nursing women
  • women of child bearing potential not using highly effective method of contraception during dosing and for 7 days after stopping study medication
  • History of hypersensitivity to any of the study drugs, including history of hypersensitivity to drugs of similar chemical classes, or allergy to angiotensin converting enzyme inhibitor (ACEIs), Angiotensin II Receptor Blockers (ARBs), or Neutral endopeptidase (NEP) inhibitors as well as known or suspected contraindications to the study drugs.
  • History of angioedema drug related or otherwise.
  • Requirement of treatment with either ACE inhibitor and/or ARB.
Show all 20Show fewer
  • Subjects with a heart transplant or ventricular assistance device (VAD) or intent to transplant (on transplant list) or implant a VAD.
  • Subjects with a cardio resynchronization therapy devices (CRT/CRT-D) implanted within 6 months of screening visit.
  • Subjects who are currently taking inotropic agents.
  • Current or prior treatment with sacubitril/valsartan.
  • Subjects taking medications prohibited by the protocol.
  • Subjects with diabetes mellitus who are taking aliskiren.
  • Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  • Concomitant use of nesiritide.
  • Bile acid sequestering agents such as cholestyramine or colestipol are prohibited to avoid interference with study drug absorption.
  • Any hospital admission/discharge related to heart failure within 2 weeks prior to baseline.
  • The use of outpatient or inpatient i.v. diuretic therapy within 2 weeks prior to baseline.
  • Enrollment in another clinical trial within 30 days of screening.
  • Potassium > 5.2 mEq/L at screening.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within one year.

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Novartis Investigative Site

    Arlington Heights, Illinois, 60005

  • Novartis Investigative Site

    Aurora, Illinois, 60504

  • Novartis Investigative Site

    Austin, Texas, 78704

  • Novartis Investigative Site

    Bakersfield, California, 93308

  • Novartis Investigative Site

    Baltimore, Maryland, 21220

  • Novartis Investigative Site

    Baltimore, Maryland, 21229

  • Novartis Investigative Site

    Beaumont, Texas, 77701

  • Novartis Investigative Site

    Belle Glade, Florida, 33430

  • Novartis Investigative Site

    Belzoni, Mississippi, 39038

  • Novartis Investigative Site

    Birmingham, Alabama, 35243

  • Novartis Investigative Site

    Boston, Massachusetts, 02114

  • Novartis Investigative Site

    Bozeman, Montana, 59715

  • Novartis Investigative Site

    Bradenton, Florida, 34209

  • Novartis Investigative Site

    Bryan, Texas, 77802

  • Novartis Investigative Site

    Buffalo, New York, 14215

  • Novartis Investigative Site

    Camp Hill, Pennsylvania, 17011

  • Novartis Investigative Site

    Columbia, Maryland, 21044

  • Novartis Investigative Site

    Crowley, Louisiana, 70526

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative Site

    Fort Payne, Alabama, 35967

  • Novartis Investigative Site

    Germantown, Tennessee, 38138

  • Novartis Investigative Site

    Greensboro, North Carolina, 27410

  • Novartis Investigative Site

    Guntersville, Alabama, 35976

  • Novartis Investigative Site

    Haverhill, Massachusetts, 01830

  • Novartis Investigative Site

    Hickory, North Carolina, 28601

  • Novartis Investigative Site

    Hillsboro, Oregon, 97123

  • Novartis Investigative Site

    Hollywood, Florida, 33312

  • Novartis Investigative Site

    Homestead, Florida, 33030

  • Novartis Investigative Site

    Houston, Texas, 77081

  • Novartis Investigative Site

    Hunstville, Texas, 77340

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Jupiter, Florida, 33458

  • Novartis Investigative Site

    Kalamazoo, Michigan, 49008

  • Novartis Investigative Site

    Lake Success, New York, 11042

  • Novartis Investigative Site

    Lake Worth, Florida, 334361

  • Novartis Investigative Site

    Lincoln, Nebraska, 68506

  • Novartis Investigative Site

    Lincoln, Nebraska, 68526

  • Novartis Investigative Site

    Lombard, Illinois, 60148

  • Novartis Investigative Site

    Long Beach, California, 90806

  • Novartis Investigative Site

    Los Alamitos, California, 90720

  • Novartis Investigative Site

    Louisville, Kentucky, 40207

  • Novartis Investigative Site

    McKinney, Texas, 75013

  • Novartis Investigative Site

    Miami, Florida, 33126

  • Novartis Investigative Site

    Miami, Florida, 33133

  • Novartis Investigative Site

    Miami, Florida, 33155

  • Novartis Investigative Site

    Miami, Florida, 33173

  • Novartis Investigative Site

    Midlothian, Virginia, 23114

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55415

  • Novartis Investigative Site

    Nashua, New Hampshire, 03060

  • Novartis Investigative Site

    Oak Lawn, Illinois, 60453

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Oregon City, Oregon, 97045

  • Novartis Investigative Site

    Owensboro, Kentucky, 42303

  • Novartis Investigative Site

    Port Orange, Florida, 32127

  • Novartis Investigative Site

    Portland, Oregon, 97225

  • Novartis Investigative Site

    Potsdam, New York, 13676

  • Novartis Investigative Site

    Richmond, Virginia, 23219

  • Novartis Investigative Site

    Richmond, Virginia, 23226

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Richmond, Virginia, 23249

  • Novartis Investigative Site

    Sherman, Texas, 75092

  • Novartis Investigative Site

    Shreveport, Louisiana, 71101

  • Novartis Investigative Site

    Simpsonville, South Carolina, 29681

  • Novartis Investigative Site

    Southhaven, Mississippi, 38671

  • Novartis Investigative Site

    Springfield, Massachusetts, 01104

  • Novartis Investigative Site

    Sylmar, California, 91342

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    Tomball, Texas, 77375

  • Novartis Investigative Site

    Tyler, Texas, 75701

  • Novartis Investigative Site

    Wellington, Florida, 33449

  • Novartis Investigative Site

    West Haven, Connecticut, 06516

  • Novartis Investigative Site

    West Monroe, Louisiana, 71291

  • Novartis Investigative Site

    White River Junction, Vermont, 05009

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

  • Novartis Investigative Site

    Wyomissing, Pennsylvania, 19610

  • Novartis Investigative Site

    Yardley, Pennsylvania, 19067

Other trials in United States

About this study

Official title: A 52 Week, Open Label Evaluation of the Effects of Sacubitril/Valsartan (LCZ696) Therapy on Biomarkers, Myocardial Remodeling and Patient-reported Outcomes in Heart Failure With Reduced Left Ventricular Ejection Fraction.

This study was to determine early and more chronic changes in concentrations of biomarkers related to mechanisms of action (MOA) and effects of sacubitril/valsartan therapy over a period of 12 months, and correlated these biomarker changes with cardiac remodeling parameters, patient-reported outcomes and cardiovascular outcomes.

Conditions
Heart Failure
Being tested
LCZ696 (sacubitril/valsartan)
Keywords
Heart failure, Reduced left ventricular ejection fraction, HFrEF, NT-proBNP, Cardiac remodeling, sacubitril/valsartan, KCCQ, biomarkers
Medical subject headings
Heart Failure

What participants receive

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

  • LCZ696 (sacubitril/valsartan)Drug

    LCZ696 (sacubitril/valsartan) was supplied as unscored, ovaloid, film-coated oral tablets in the strengths of 24/26 mg, 49/51 mg, 97/103 mg to be taken twice daily (bid)

Study groups in NCT02887183
Study groupRoleWhat they receive
LCZ696(sacubitril/valsartan)OtherSubjects received sacubitril/valsartan (LCZ696) on Day 1. The initial dose was determined by the investigator and per the approved indication described in the United States prescribing information/package insert (USPI). The three doses available were: 24/26 mg (Dose Level 1), 49/51mg (Dose Level 2) and 97/103mg (Dose Level 3). Titration of the dosage were performed per USPI at 2 to 4 week intervals as clinically tolerated until maximal tolerated or target dosage was achieved. Target dosage was sacubitril/valsartan 97/103 mg twice daily.
Receives: Drug: LCZ696 (sacubitril/valsartan)

What is being measured

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

  1. Change in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to One Year

    Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to one year

    Measured: Baseline, one year

  2. Change in Left Atrial Volume Index (LAVi), Left Ventricular End Diastolic Volume Index (LVEDVi), Left Ventricular End Systolic Volume Index (LVESVi), and From Baseline to One Year

    Change in left atrial volume index (LAVi), left ventricular end diastolic volume index (LVEDVi), left ventricular end systolic volume index (LVESVi), and from baseline to one year

    Measured: Baseline, one Year

  3. Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to One Year

    Change in Left ventricular ejection fraction (LVEF) from baseline to one year. LVEF is a measurement expressed as a percentage of how much blood the left ventricle pumps out with each contraction.

    Measured: Baseline, one year

  4. Change in Log-transformed NT-proBNP and Change in Structural Cardiac Measurements LVESVi, LVEDVi, LAVi, and LVEF From Baseline to One Year

    Pearson's correlation coefficient was calculated between change in log-transformed NT-proBNP and change in structural cardiac measurements LVESVi, LVEDVi, LAVi, and LVEF from baseline to one year.

    Measured: Baseline, one year

Secondary outcomes (6)

  1. Change in Log-transformed NT-proBNP Concentration and Change in Echocardiographic Measurements LVESVi, LVEDVi, LAVi, and LVEF From Baseline to Month 6

    Pearson's correlation coefficient was calculated between change in log-transformed NT-proBNP and change in echocardiographic measurements LVESVi, LVEDVi, LAVi, and LVEF from baseline to Month 6

    Measured: Baseline, Month 6

  2. Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Change in Left Atrial Volume Index (LAVi) by Selected Groups of Interest at Month 6

    Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LAVi from baseline to 6 months overall in subgroups of interest, these subgroups are:

    1. Subjects with HFrEF and "low" NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or "low" BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.
    2. Subjects with new onset HF and/or RAAS naïve.
    3. Subjects who are not receiving the target sacubitril/valsartan dose.

    Measured: Baseline, Month 6

  3. Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular End Systolic Volume Index (LVESVi) by Selected Groups of Interest at Month 6

    Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVESVi from baseline to 6 months overall in subgroups of interest, these subgroups are:

    1. Subjects with HFrEF and "low" NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or "low" BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.
    2. Subjects with new onset HF and/or RAAS naïve.
    3. Subjects who are not receiving the target sacubitril/valsartan dose.

    Measured: Baseline, Month 6

  4. Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular End Diastolic Volume Index (LVEDVi) by Selected Groups of Interest at Month 6

    Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVEDVi from baseline to 6 months overall in subgroups of interest, these subgroups are:

    1. Subjects with HFrEF and "low" NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or "low" BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.
    2. Subjects with new onset HF and/or RAAS naïve.
    3. Subjects who are not receiving the target sacubitril/valsartan dose.

    Measured: Baseline, Month 6

  5. Change From Baseline in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) and Change in Left Ventricular Ejection Fraction (LVEF) by Selected Groups of Interest at Month 6

    Pearson's correlation coefficient to examine the association between change in log-transformed NT-proBNP and LVEF from baseline to 6 months overall in subgroups of interest, these subgroups are:

    1. Subjects with HFrEF and "low" NT-proBNP (<600 if not hospitalized or <400 if hospitalized) or "low" BNP (<150 if not hospitalized, <100 if hospitalized) at baseline.
    2. Subjects with new onset HF and/or RAAS naïve.
    3. Subjects who are not receiving the target sacubitril/valsartan dose.

    Measured: Baseline, Month 6

  6. Mean Change in the Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Clinical Summary Score From Baseline to Month 12

    The KCCQ-23 is a self-administered questionnaire and requires, on average, 4-6 minutes to complete. It contains 23 items, covering physical function, clinical symptoms, social function, self-efficacy and knowledge, and Quality of Life (QoL). A change of 5 points on the scale scores, either as a group mean difference or an intra-individual change appears to be clinically significant, based on comparisons of changes in the scale scores to clinical indicators and subject global reports of change. The analysis will be done for groups of subjects with N-terminal pro-brain natriuretic peptide<1000 pg/mL and N-Terminal pro-brain natriuretic peptide>=1000 pg/mL at Month 12.

    Measured: Baseline, month 12

Timeline

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

  1. First posted2 Sep 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion22 Oct 2018
  4. Study completion22 Oct 2018

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 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887183
Sponsor's protocol ID
CLCZ696BUS13
Acronym
PROVE-HF
Status last verified
Oct 2021
First submitted
29 Aug 2016
Last updated
7 Oct 2021
Data monitoring committee
No
FDA-regulated drug
Yes
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

  • Omar AMS, Murphy S, Felker GM, Pina I, Butler J, Liu Y, Mohebi R, Bhatia K, Ward JH, Williamson KM, Solomon SD, Januzzi JL, Contreras J. Isovolumic Contraction Velocity in Heart Failure With Reduced Ejection Fraction and Effect of Sacubitril/Valsartan: the PROVE-HF Study. J Card Fail. 2024 May;30(5):653-665. doi: 10.1016/j.cardfail.2023.10.001. Epub 2023 Oct 8.

    PubMed 37816446

  • Myhre PL, Liu Y, Kulac IJ, Claggett BL, Prescott MF, Felker GM, Butler J, Pina IL, Rouleau JL, Zile MR, McMurray JJV, Ward JH, Solomon SD, Januzzi JL. Changes in mid-regional pro-adrenomedullin during treatment with sacubitril/valsartan. Eur J Heart Fail. 2023 Aug;25(8):1396-1405. doi: 10.1002/ejhf.2957. Epub 2023 Jul 11.

    PubMed 37401523

  • Mohebi R, Liu Y, Felker GM, Prescott MF, Pina IL, Butler J, Ward JH, Solomon SD, Januzzi JL. Prediction of Left Ventricular Ejection Fraction Change Following Treatment With Sacubitril/Valsartan. JACC Heart Fail. 2023 Jan;11(1):44-54. doi: 10.1016/j.jchf.2022.09.009. Epub 2022 Nov 9.

    PubMed 36599549

  • Murphy SP, Ward JH, Pina IL, Felker GM, Butler J, Maisel AS, Meng X, Prescott MF, Solomon SD, Januzzi JL. Age Differences in Effects of Sacubitril/Valsartan on Cardiac Remodeling, Biomarkers, and Health Status. JACC Heart Fail. 2022 Dec;10(12):976-988. doi: 10.1016/j.jchf.2022.07.001. Epub 2022 Sep 7.

    PubMed 36456072

  • Mohebi R, Liu Y, Pina IL, Prescott MF, Butler J, Felker GM, Ward JH, Solomon SD, Januzzi JL Jr. Dose-Response to Sacubitril/Valsartan in Patients With Heart Failure and Reduced Ejection Fraction. J Am Coll Cardiol. 2022 Oct 18;80(16):1529-1541. doi: 10.1016/j.jacc.2022.08.737.

    PubMed 36229089

  • Myhre PL, Prescott MF, Claggett B, Felker GM, Butler J, Pina IL, Maisel AS, Williamson KM, Ward JH, Solomon SD, Januzzi JL. Comparative Effect of Angiotensin Receptor Neprilysin Inhibition on B-type Natriuretic Peptide Levels Measured by Three Different Assays: The PROVE-HF Study. Clin Chem. 2022 Nov 3;68(11):1391-1398. doi: 10.1093/clinchem/hvac148.

    PubMed 36103292

  • Myhre PL, Prescott MF, Murphy SP, Fang JC, Mitchell GF, Ward JH, Claggett B, Desai AS, Solomon SD, Januzzi JL. Early B-Type Natriuretic Peptide Change in HFrEF Patients Treated With Sacubitril/Valsartan: A Pooled Analysis of EVALUATE-HF and PROVE-HF. JACC Heart Fail. 2022 Feb;10(2):119-128. doi: 10.1016/j.jchf.2021.09.007. Epub 2022 Jan 12.

    PubMed 35115085

  • Murphy SP, Prescott MF, Maisel AS, Butler J, Pina IL, Felker GM, Ward JH, Williamson KM, Camacho A, Kandanelly RR, Solomon SD, Januzzi JL. Association Between Angiotensin Receptor-Neprilysin Inhibition, Cardiovascular Biomarkers, and Cardiac Remodeling in Heart Failure With Reduced Ejection Fraction. Circ Heart Fail. 2021 Jun;14(6):e008410. doi: 10.1161/CIRCHEARTFAILURE.120.008410. Epub 2021 May 15.

    PubMed 33998243

  • Khan MS, Felker GM, Pina IL, Camacho A, Bapat D, Ibrahim NE, Maisel AS, Prescott MF, Ward JH, Solomon SD, Januzzi JL, Butler J. Reverse Cardiac Remodeling Following Initiation of Sacubitril/Valsartan in Patients With Heart Failure With and Without Diabetes. JACC Heart Fail. 2021 Feb;9(2):137-145. doi: 10.1016/j.jchf.2020.09.014. Epub 2020 Dec 9.

    PubMed 33309581

  • Murphy SP, Prescott MF, Camacho A, Iyer SR, Maisel AS, Felker GM, Butler J, Pina IL, Ibrahim NE, Abbas C, Burnett JC Jr, Solomon SD, Januzzi JL. Atrial Natriuretic Peptide and Treatment With Sacubitril/Valsartan in Heart Failure With Reduced Ejection Fraction. JACC Heart Fail. 2021 Feb;9(2):127-136. doi: 10.1016/j.jchf.2020.09.013. Epub 2020 Nov 11.

    PubMed 33189632

  • Pina IL, Camacho A, Ibrahim NE, Felker GM, Butler J, Maisel AS, Prescott MF, Williamson KM, Claggett BL, Desai AS, Solomon SD, Januzzi JL; PROVE-HF Investigators. Improvement of Health Status Following Initiation of Sacubitril/Valsartan in Heart Failure and Reduced Ejection Fraction. JACC Heart Fail. 2021 Jan;9(1):42-51. doi: 10.1016/j.jchf.2020.09.012. Epub 2020 Nov 11.

    PubMed 33189630

  • Ibrahim NE, Pina IL, Camacho A, Bapat D, Felker GM, Maisel AS, Butler J, Prescott MF, Abbas CA, Solomon SD, Januzzi JL Jr; Prospective Study of Biomarkers, Symptom Improvement and Ventricular Remodeling During Entresto Therapy for Heart Failure (PROVE-HF) Study Investigators. Racial and Ethnic Differences in Biomarkers, Health Status, and Cardiac Remodeling in Patients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan. Circ Heart Fail. 2020 Nov;13(11):e007829. doi: 10.1161/CIRCHEARTFAILURE.120.007829. Epub 2020 Oct 3.

    PubMed 33016100

  • Januzzi JL Jr, Prescott MF, Butler J, Felker GM, Maisel AS, McCague K, Camacho A, Pina IL, Rocha RA, Shah AM, Williamson KM, Solomon SD; PROVE-HF Investigators. Association of Change in N-Terminal Pro-B-Type Natriuretic Peptide Following Initiation of Sacubitril-Valsartan Treatment With Cardiac Structure and Function in Patients With Heart Failure With Reduced Ejection Fraction. JAMA. 2019 Sep 17;322(11):1085-1095. doi: 10.1001/jama.2019.12821.

    PubMed 31475295

  • Januzzi JL, Butler J, Fombu E, Maisel A, McCague K, Pina IL, Prescott MF, Riebman JB, Solomon S. Rationale and methods of the Prospective Study of Biomarkers, Symptom Improvement, and Ventricular Remodeling During Sacubitril/Valsartan Therapy for Heart Failure (PROVE-HF). Am Heart J. 2018 May;199:130-136. doi: 10.1016/j.ahj.2017.12.021. Epub 2018 Feb 13.

    PubMed 29754651

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LCZ696 (sacubitril/valsartan) in people with Heart Failure, run by Novartis Pharmaceuticals at 77 sites in United States.

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 20 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 7 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 77 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 5 Dec 2019). 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 in Concentration of N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to One Year (time frame: Baseline, one year). The study lists 4 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 NCT02887183, which also lists 14 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 7 Oct 2021.

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