Comparison of Sacubitril/Valsartan Versus Enalapril on Effect on NT-proBNP in Patients Stabilized From an Acute Heart Failure Episode. (PIONEER-HF)

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled 8-week Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Enalapril on Changes in NT-proBNP and Safety and Tolerability of In-hospital Initiation of LCZ696 Compared to Enalapril in HFrEF Patients Who Have Been Stabilized Following Hospitalization for Acute Decompensated Heart Failure (ADHF).

The purpose of this study was to assess the effect of in-hospital initiation of sacubitril/valsartan (LCZ696) vs. enalapril on time averaged proportional change in NT-proBNP in patients who have been stabilized following hospitalization for acute decompensated heart failure (ADHF) and reduced ejection fraction (left ventricular ejection fraction (LVEF) ≤ 40%).

Study Overview

• Status: Completed
• Conditions: Acute Heart Failure
• Intervention / Treatment: Drug: sacubitril/valsartan (LCZ696); Drug: enalapril matching placebo; Drug: Enalapril; Drug: sacubitril/valsartan (LCZ696) matching placebo

• Study Type: Interventional
• Enrollment (Actual): 887
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Novartis Investigative Site
  • Arkansas
    • Fort Smith, Arkansas, United States, 72901
      • Novartis Investigative Site
    • Little Rock, Arkansas, United States, 72205
      • Novartis Investigative Site
  • California
    • Bakersfield, California, United States, 93301
      • Novartis Investigative Site
    • Fresno, California, United States, 93701
      • Novartis Investigative Site
    • Long Beach, California, United States, 90806
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90033
      • Novartis Investigative Site
    • Los Angeles, California, United States, 90073
      • Novartis Investigative Site
    • Orange, California, United States, 92868
      • Novartis Investigative Site
    • Pasadena, California, United States, 91105
      • Novartis Investigative Site
    • Sacramento, California, United States, 95817-1460
      • Novartis Investigative Site
    • San Diego, California, United States, 92123
      • Novartis Investigative Site
    • San Marino, California, United States, 91108
      • Novartis Investigative Site
    • San Pablo, California, United States, 94806
      • Novartis Investigative Site
    • Stanford, California, United States, 94305
      • Novartis Investigative Site
  • Colorado
    • Denver, Colorado, United States
      • Novartis Investigative Site
    • Littleton, Colorado, United States, 80120
      • Novartis Investigative Site
  • Connecticut
    • Bridgeport, Connecticut, United States, 06610
      • Novartis Investigative Site
    • Hartford, Connecticut, United States, 06105
      • Novartis Investigative Site
    • Hartford, Connecticut, United States, 06102
      • Novartis Investigative Site
    • West Haven, Connecticut, United States, 06516
      • Novartis Investigative Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20422
      • Novartis Investigative Site
  • Florida
    • Atlantis, Florida, United States, 33462
      • Novartis Investigative Site
    • Daytona Beach, Florida, United States, 32117
      • Novartis Investigative Site
    • Fort Lauderdale, Florida, United States, 33308
      • Novartis Investigative Site
    • Gainesville, Florida, United States, 32608
      • Novartis Investigative Site
    • Gainesville, Florida, United States, 32610
      • Novartis Investigative Site
    • Hollywood, Florida, United States, 33021
      • Novartis Investigative Site
    • Jacksonville, Florida, United States, 32216
      • Novartis Investigative Site
    • Jacksonville, Florida, United States, 32209-6511
      • Novartis Investigative Site
    • Lakeland, Florida, United States, 33805
      • Novartis Investigative Site
    • Sarasota, Florida, United States, 34239
      • Novartis Investigative Site
    • Tampa, Florida, United States, 33612
      • Novartis Investigative Site
    • Tampa, Florida, United States, 34667
      • Novartis Investigative Site
    • Vero Beach, Florida, United States, 32960
      • Novartis Investigative Site
    • Winter Haven, Florida, United States, 33881
      • Novartis Investigative Site
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Novartis Investigative Site
    • Macon, Georgia, United States, 31201
      • Novartis Investigative Site
    • Marietta, Georgia, United States, 30060
      • Novartis Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83702
      • Novartis Investigative Site
  • Illinois
    • Aurora, Illinois, United States, 60504
      • Novartis Investigative Site
    • Elk Grove Village, Illinois, United States, 60007
      • Novartis Investigative Site
    • Oakbrook Terrace, Illinois, United States, 60181
      • Novartis Investigative Site
    • Park Ridge, Illinois, United States, 60068
      • Novartis Investigative Site
    • Peoria, Illinois, United States, 61614
      • Novartis Investigative Site
    • Peoria, Illinois, United States, 61606
      • Novartis Investigative Site
    • Winfield, Illinois, United States, 60190
      • Novartis Investigative Site
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Novartis Investigative Site
    • Indianapolis, Indiana, United States, 46202
      • Novartis Investigative Site
    • Indianapolis, Indiana, United States, 46237
      • Novartis Investigative Site
    • Muncie, Indiana, United States, 47303-3400
      • Novartis Investigative Site
    • Richmond, Indiana, United States, 47374
      • Novartis Investigative Site
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Novartis Investigative Site
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Novartis Investigative Site
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Novartis Investigative Site
    • Louisville, Kentucky, United States, 40245
      • Novartis Investigative Site
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
      • Novartis Investigative Site
    • Baton Rouge, Louisiana, United States, 70808
      • Novartis Investigative Site
    • Slidell, Louisiana, United States, 70458
      • Novartis Investigative Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Novartis Investigative Site
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Novartis Investigative Site
    • Baltimore, Maryland, United States, 21215
      • Novartis Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Novartis Investigative Site
    • Boston, Massachusetts, United States
      • Novartis Investigative Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Novartis Investigative Site
    • Bay City, Michigan, United States, 48708
      • Novartis Investigative Site
    • Detroit, Michigan, United States, 48201
      • Novartis Investigative Site
  • Minnesota
    • Maplewood, Minnesota, United States, 55109
      • Novartis Investigative Site
    • Minneapolis, Minnesota, United States, 55417
      • Novartis Investigative Site
    • Saint Paul, Minnesota, United States, 55101
      • Novartis Investigative Site
    • Saint Paul, Minnesota, United States, 55102
      • Novartis Investigative Site
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Novartis Investigative Site
    • Jackson, Mississippi, United States, 39216
      • Novartis Investigative Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Novartis Investigative Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Novartis Investigative Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • Novartis Investigative Site
  • New Jersey
    • Camden, New Jersey, United States, 08103-3117
      • Novartis Investigative Site
    • Elmer, New Jersey, United States, 08318
      • Novartis Investigative Site
    • Haddon Heights, New Jersey, United States, 08035
      • Novartis Investigative Site
    • Newark, New Jersey, United States, 07102
      • Novartis Investigative Site
  • New York
    • Bronx, New York, United States, 10461
      • Novartis Investigative Site
    • Bronx, New York, United States, 10467-2490
      • Novartis Investigative Site
    • Brooklyn, New York, United States, 11215
      • Novartis Investigative Site
    • Buffalo, New York, United States, 14215
      • Novartis Investigative Site
    • Johnson City, New York, United States, 13790
      • Novartis Investigative Site
    • Manhasset, New York, United States, 11030
      • Novartis Investigative Site
    • New York, New York, United States, 10016
      • Novartis Investigative Site
    • New York, New York, United States, 10029
      • Novartis Investigative Site
    • New York, New York, United States, 10032
      • Novartis Investigative Site
    • Poughkeepsie, New York, United States, 12601
      • Novartis Investigative Site
    • Rochester, New York, United States, 14621
      • Novartis Investigative Site
    • Staten Island, New York, United States, 10310
      • Novartis Investigative Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Novartis Investigative Site
    • Greenville, North Carolina, United States, 27834
      • Novartis Investigative Site
    • Winston-Salem, North Carolina, United States, 27157
      • Novartis Investigative Site
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Novartis Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Novartis Investigative Site
    • Toledo, Ohio, United States, 43608
      • Novartis Investigative Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73122
      • Novartis Investigative Site
    • Tulsa, Oklahoma, United States, 74104
      • Novartis Investigative Site
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Novartis Investigative Site
    • Camp Hill, Pennsylvania, United States, 17011
      • Novartis Investigative Site
    • Natrona Heights, Pennsylvania, United States, 15065
      • Novartis Investigative Site
    • Philadelphia, Pennsylvania, United States, 19102 2293
      • Novartis Investigative Site
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Novartis Investigative Site
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Novartis Investigative Site
    • Greenville, South Carolina, United States, 29615
      • Novartis Investigative Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Novartis Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Novartis Investigative Site
    • Nashville, Tennessee, United States, 37212
      • Novartis Investigative Site
  • Texas
    • Dallas, Texas, United States, 75204
      • Novartis Investigative Site
    • Dallas, Texas, United States, 75390
      • Novartis Investigative Site
    • Houston, Texas, United States, 77030
      • Novartis Investigative Site
    • Plano, Texas, United States, 75093
      • Novartis Investigative Site
    • San Antonio, Texas, United States, 78229
      • Novartis Investigative Site
  • Vermont
    • White River Junction, Vermont, United States, 05009
      • Novartis Investigative Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Novartis Investigative Site
    • Lynchburg, Virginia, United States, 24501
      • Novartis Investigative Site
    • Richmond, Virginia, United States, 23298
      • Novartis Investigative Site
    • Virginia Beach, Virginia, United States, 23454
      • Novartis Investigative Site
  • West Virginia
    • Clarksburg, West Virginia, United States, 26301
      • Novartis Investigative Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-1615
      • Novartis Investigative Site
    • Wausau, Wisconsin, United States, 54401
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Possess the capacity to provide written informed consent which must be obtained before any assessment is performed.
2. Currently hospitalized for ADHF. Patients with a diagnosis of acute heart failure had to have symptoms and signs of fluid overload (i.e. jugular venous distention, edema or rales on auscultation or pulmonary congestion on chest x-ray) at time of hospitalization.

3. Eligible patients will be randomized no earlier than 24 hours and up to ten days after presentation while still hospitalized as long as meet the following definition of stable status:

   • SBP ≥100mm Hg for the preceding 6 hours prior to randomization; no symptomatic hypotension
   • No increase (intensification) in i.v. diuretic dose within last 6 hours prior to randomization
   • No i.v. inotropic drugs for 24 hours prior to randomization
   • No i.v. vasodilators including nitrates within last 6 hours prior to randomization
4. LVEF ≤40% within the past 6 months (including current hospitalization) using echocardiography, multi gated acquisition scan (MUGA), CT scanning, MRI or ventricular angiography, provided no subsequent study documented an EF of >40%.
5. Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.

Key Exclusion Criteria:

1. Currently taking sacubitril/valsartan tablets or any use within the past 30 days.
2. Enrollment in any other clinical trial involving an investigational agent or investigational device.
3. History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs, including ACEIs, ARBs, or Sacubitril (NEP inhibitor).
4. Patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy.
5. Requirement of treatment with both ACE inhibitor and ARB.
6. eGFR < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening.
7. Serum potassium > 5.2 mEq/L at screening.
8. Known hepatic impairment (as evidenced by total bilirubin > 3 mg/dL, or increased ammonia levels, if performed), or history of cirrhosis with evidence of portal hypertension such as varices
9. Acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid or other major CV surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, within one month prior to Visit 1.
10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
11. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sacubitril/valsartan (LCZ696); Initial dose for patients randomized to sacubitril/valsartan (LCZ696) was determined by the blood pressure at the time of randomization. Study treatment was titrated to the target dose of sacubitril/valsartan (LCZ696) 97/103 mg bid (Dose Level 3). Titration was based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement. Patients were required to take a total of two tablets twice daily (one tablet of active sacubitril and valsartan and one tablet of enalapril matching placebo pack).	Drug: sacubitril/valsartan (LCZ696); sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.; Other Names: LCZ696; Drug: enalapril matching placebo; enalapril matching placebo tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.
Active Comparator: Enalapril; Initial dose for patients randomized to enalapril were determined by the blood pressure at the time of randomization. Study treatment were titrated to the target dose of enalapril 10 mg bid. Titration were based on blood pressure at the time of the visit. Dose adjustments were only allowed if indicated per protocol defined safety and tolerability criteria and investigator judgement. Patients were required to take a total of two tablets twice daily (one tablet of active enalapril, second from sacubitril and valsartan matching placebo pack)	Drug: Enalapril; Enalapril tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.; Drug: sacubitril/valsartan (LCZ696) matching placebo; matching placebo of sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline	To assess the effect of in-hospital initiation of sacubitril/valsartan vs. enalapril on the time-averaged percentage change of NT-proBNP from baseline in patients who have been stabilized following hospitalization for ADHF and reduced ejection fraction (left ventricular ejection fraction [LVEF] ≤ 40%) between week 4 and 8. Number of patients with both a baseline value and a value at Week 4 or Week 8. Plasma NT-proBNP (pg/mL) values were averaged from Week 4 and Week 8 visits. N-terminal pro b-type natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder, as in heart failure.	Baseline, Week 4 and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Incidences of Symptomatic Hypotension	Examine the effect of LCZ696 vs. enalapril on incidence of symptomatic hypotension during 8 weeks of treatment Hypotension is low blood pressure. Patients with hypotension may experience symptoms when their blood pressure drops, compared to the patient's normal values. Symptoms of hypotension can include dizziness, lightheadedness, blurred vision, weakness, fatigue, nausea, palpitations, and headache.	8 weeks of treatment
Number of Patients With Incidences of Hyperkalemia	Hyperkalemia is defined as Potassium level >5.5 mEq/L. Hyperkalemia is the medical term that describes a potassium level in your blood that's higher than normal. Potassium is a chemical that is critical to the function of nerve and muscle cells, including those in your heart.	8 weeks of treatment
Number of Patients With Incidences of Angioedema	Angioedema is a type of abrupt swelling that occurs under the skin and/or mucous membranes and is often localized to the head, neck, throat, and/or tongue, but may occur elsewhere, including the genitalia and intestines. Severe cases may be associated with difficulty in breathing.	8 weeks of treatment
Change From Baseline in High Sensitivity Troponin (Hs-Troponin)	time-averaged (Weeks 4 and 8) change from baseline in hs-troponin T. hs-Troponin-T is a biomarker that is released from the heart under stress or injury conditions.	Baseline, Week 4/Week 8
Change From Baseline in Urinary cGMP	Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP. Urinary Cyclic GMP (cGMP) is a biomarker measured in the urine that reflects the activity of biomarkers such as BNP (Brain Natriuretic Peptide)	Baseline, Week 4 and Week 8
Change From Baseline in Urinary cGMP to Urinary Creatinine Ratio	Time-averaged (Weeks 4 and 8) change from baseline in urinary cGMP to urinary creatinine ratio. Urinary cGMP to urinary creatinine ratio is how much urinary cGMP (which reflects natriuretic peptide activity) compared to a compound in the urine called creatinine (which helps your doctor evaluate how well your kidneys are functioning).	Baseline, Week 4 and Week 8
Change From Baseline in BNP to NTproBNP Ratio	Time-averaged (Weeks 4 and 8) change from baseline in BNP to NT-proBNP ratio. BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure.	baseline, Week 4 and Week 8
N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Change From Baseline at Week 8	BNP and NT-proBNP are small proteins produced in large amounts when the heart senses it needs to work harder, such as in heart failure. The test measuring BNP to NT-proBNP is measuring how much of each of these biomarkers are present in order to evaluate heart failure. Plasma NT-proBNP (pg/mL) values were Week 8 visit.	Baseline, Week 8

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

General Publications

• Velazquez EJ, Morrow DA, DeVore AD, Duffy CI, Ambrosy AP, McCague K, Rocha R, Braunwald E; PIONEER-HF Investigators. Angiotensin-Neprilysin Inhibition in Acute Decompensated Heart Failure. N Engl J Med. 2019 Feb 7;380(6):539-548. doi: 10.1056/NEJMoa1812851. Epub 2018 Nov 11. Erratum In: N Engl J Med. 2019 Mar 14;380(11):1090.
• Velazquez EJ, Morrow DA, DeVore AD, Ambrosy AP, Duffy CI, McCague K, Hernandez AF, Rocha RA, Braunwald E. Rationale and design of the comParIson Of sacubitril/valsartaN versus Enalapril on Effect on nt-pRo-bnp in patients stabilized from an acute Heart Failure episode (PIONEER-HF) trial. Am Heart J. 2018 Apr;198:145-151. doi: 10.1016/j.ahj.2018.01.004. Epub 2018 Jan 10.
• Morrow DA, Velazquez EJ, DeVore AD, Desai AS, Duffy CI, Ambrosy AP, Gurmu Y, McCague K, Rocha R, Braunwald E. Clinical Outcomes in Patients With Acute Decompensated Heart Failure Randomly Assigned to Sacubitril/Valsartan or Enalapril in the PIONEER-HF Trial. Circulation. 2019 May 7;139(19):2285-2288. doi: 10.1161/CIRCULATIONAHA.118.039331. No abstract available.
• Morrow DA, Velazquez EJ, DeVore AD, Prescott MF, Duffy CI, Gurmu Y, McCague K, Rocha R, Braunwald E. Cardiovascular biomarkers in patients with acute decompensated heart failure randomized to sacubitril-valsartan or enalapril in the PIONEER-HF trial. Eur Heart J. 2019 Oct 21;40(40):3345-3352. doi: 10.1093/eurheartj/ehz240.
• Berardi C, Braunwald E, Morrow DA, Mulder HS, Duffy CI, O'Brien TX, Ambrosy AP, Chakraborty H, Velazquez EJ, DeVore AD; PIONEER-HF Investigators. Angiotensin-Neprilysin Inhibition in Black Americans: Data From the PIONEER-HF Trial. JACC Heart Fail. 2020 Oct;8(10):859-866. doi: 10.1016/j.jchf.2020.06.019. Epub 2020 Sep 9.
• Ambrosy AP, Braunwald E, Morrow DA, DeVore AD, McCague K, Meng X, Duffy CI, Rocha R, Velazquez EJ; PIONEER-HF Investigators. Angiotensin Receptor-Neprilysin Inhibition Based on History of Heart Failure and Use of Renin-Angiotensin System Antagonists. J Am Coll Cardiol. 2020 Sep 1;76(9):1034-1048. doi: 10.1016/j.jacc.2020.06.073.
• Berg DD, Braunwald E, DeVore AD, Lala A, Pinney SP, Duffy CI, Gurmu Y, Velazquez EJ, Morrow DA. Efficacy and Safety of Sacubitril/Valsartan by Dose Level Achieved in the PIONEER-HF Trial. JACC Heart Fail. 2020 Oct;8(10):834-843. doi: 10.1016/j.jchf.2020.06.008. Epub 2020 Aug 12.
• DeVore AD, Braunwald E, Morrow DA, Duffy CI, Ambrosy AP, Chakraborty H, McCague K, Rocha R, Velazquez EJ; PIONEER-HF Investigators. Initiation of Angiotensin-Neprilysin Inhibition After Acute Decompensated Heart Failure: Secondary Analysis of the Open-label Extension of the PIONEER-HF Trial. JAMA Cardiol. 2020 Feb 1;5(2):202-207. doi: 10.1001/jamacardio.2019.4665.

Helpful Links

• A Plain Language Trial Summary is available on novartisclinicatrials.com

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2016
• Primary Completion (Actual): June 29, 2018
• Study Completion (Actual): July 24, 2018

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; NTproBNP; Acute; reduced ejection fraction; Heart failure with reduced ejection fraction (HFREF)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Angiotensin-Converting Enzyme Inhibitors; Valsartan; Enalaprilat; Enalapril; Sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: CLCZ696BUS01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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