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Acute Heart FailurePhase 4PIONEER-HFNCT02554890

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

A Phase 4 study testing sacubitril/valsartan (LCZ696) and Enalapril in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 123 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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Heart Failure
What is being tested?
sacubitril/valsartan (LCZ696) and Enalapril
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
887 participants
Where
123 sitesUnited States
Study dates
29 Apr 2016to 24 Jul 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

  • Possess the capacity to provide written informed consent which must be obtained before any assessment is performed.
  • 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.
  • 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
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  • No i.v. vasodilators including nitrates within last 6 hours prior to randomization
  • 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%.
  • Elevated NT-proBNP ≥ 1600pg/mL OR BNP ≥400 pg/mL during current hospitalization.

Who cannot join

  • Currently taking sacubitril/valsartan tablets or any use within the past 30 days.
  • Enrollment in any other clinical trial involving an investigational agent or investigational device.
  • History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs, including ACEIs, ARBs, or Sacubitril (NEP inhibitor).
  • Patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy.
  • Requirement of treatment with both ACE inhibitor and ARB.
  • eGFR < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening.
Show all 11Show fewer
  • Serum potassium > 5.2 mEq/L at screening.
  • 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
  • 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.
  • 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.
  • 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.

Trial locations and contacts

123 sites in 1 country.

123 sites in 1 country

United States123 sites

  • Novartis Investigative Site

    Abington, Pennsylvania, 19001

  • Novartis Investigative Site

    Alexandria, Louisiana, 71301

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48106

  • Novartis Investigative Site

    Annapolis, Maryland, 21401

  • Novartis Investigative Site

    Atlantis, Florida, 33462

  • Novartis Investigative Site

    Augusta, Georgia, 30901

  • Novartis Investigative Site

    Aurora, Illinois, 60504

  • Novartis Investigative Site

    Bakersfield, California, 93301

  • Novartis Investigative Site

    Baltimore, Maryland, 21215

  • Novartis Investigative Site

    Bangor, Maine, 04401

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70808

  • Novartis Investigative Site

    Bay City, Michigan, 48708

  • Novartis Investigative Site

    Birmingham, Alabama, 35294

  • Novartis Investigative Site

    Boise, Idaho, 83702

  • Novartis Investigative Site

    Boston, Massachusetts, 02215

  • Novartis Investigative Site

    Boston, Massachusetts

  • Novartis Investigative Site

    Bridgeport, Connecticut, 06610

  • Novartis Investigative Site

    Brooklyn, New York, 11215

  • Novartis Investigative Site

    Buffalo, New York, 14215

  • Novartis Investigative Site

    Camden, New Jersey, 08103-3117

  • Novartis Investigative Site

    Camp Hill, Pennsylvania, 17011

  • Novartis Investigative Site

    Chapel Hill, North Carolina, 27599

  • Novartis Investigative Site

    Charleston, South Carolina, 29403

  • Novartis Investigative Site

    Charlottesville, Virginia, 22908

  • Novartis Investigative Site

    Cincinnati, Ohio, 45220

  • Novartis Investigative Site

    Clarksburg, West Virginia, 26301

  • Novartis Investigative Site

    Dallas, Texas, 75204

  • Novartis Investigative Site

    Dallas, Texas, 75390

  • Novartis Investigative Site

    Daytona Beach, Florida, 32117

  • Novartis Investigative Site

    Denver, Colorado

  • Novartis Investigative Site

    Des Moines, Iowa, 50314

  • Novartis Investigative Site

    Detroit, Michigan, 48201

  • Novartis Investigative Site

    Elk Grove Village, Illinois, 60007

  • Novartis Investigative Site

    Elkhart, Indiana, 46514

  • Novartis Investigative Site

    Elmer, New Jersey, 08318

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33308

  • Novartis Investigative Site

    Fort Smith, Arkansas, 72901

  • Novartis Investigative Site

    Fresno, California, 93701

  • Novartis Investigative Site

    Gainesville, Florida, 32608

  • Novartis Investigative Site

    Gainesville, Florida, 32610

  • Novartis Investigative Site

    Grand Forks, North Dakota, 58201

  • Novartis Investigative Site

    Greenville, North Carolina, 27834

  • Novartis Investigative Site

    Greenville, South Carolina, 29615

  • Novartis Investigative Site

    Haddon Heights, New Jersey, 08035

  • Novartis Investigative Site

    Hartford, Connecticut, 06102

  • Novartis Investigative Site

    Hartford, Connecticut, 06105

  • Novartis Investigative Site

    Hattiesburg, Mississippi, 39401

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Indianapolis, Indiana, 46237

  • Novartis Investigative Site

    Jackson, Mississippi, 39216

  • Novartis Investigative Site

    Jacksonville, Florida, 32209-6511

  • Novartis Investigative Site

    Jacksonville, Florida, 32216

  • Novartis Investigative Site

    Johnson City, New York, 13790

  • Novartis Investigative Site

    Kansas City, Kansas, 66103

  • Novartis Investigative Site

    Kansas City, Missouri, 64108

  • Novartis Investigative Site

    Lakeland, Florida, 33805

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Littleton, Colorado, 80120

  • Novartis Investigative Site

    Long Beach, California, 90806

  • Novartis Investigative Site

    Los Angeles, California, 90033

  • Novartis Investigative Site

    Los Angeles, California, 90073

  • Novartis Investigative Site

    Louisville, Kentucky, 40205

  • Novartis Investigative Site

    Louisville, Kentucky, 40245

  • Novartis Investigative Site

    Lynchburg, Virginia, 24501

  • Novartis Investigative Site

    Macon, Georgia, 31201

  • Novartis Investigative Site

    Madison, Wisconsin, 53792-1615

  • Novartis Investigative Site

    Manhasset, New York, 11030

  • Novartis Investigative Site

    Maplewood, Minnesota, 55109

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Minneapolis, Minnesota, 55417

  • Novartis Investigative Site

    Muncie, Indiana, 47303-3400

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    Nashville, Tennessee, 37212

  • Novartis Investigative Site

    Natrona Heights, Pennsylvania, 15065

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    New York, New York, 10029

  • Novartis Investigative Site

    New York, New York, 10032

  • Novartis Investigative Site

    Newark, New Jersey, 07102

  • Novartis Investigative Site

    Oakbrook Terrace, Illinois, 60181

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73122

  • Novartis Investigative Site

    Omaha, Nebraska, 68198

  • Novartis Investigative Site

    Orange, California, 92868

  • Novartis Investigative Site

    Park Ridge, Illinois, 60068

  • Novartis Investigative Site

    Pasadena, California, 91105

  • Novartis Investigative Site

    Peoria, Illinois, 61606

  • Novartis Investigative Site

    Peoria, Illinois, 61614

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19102 2293

  • Novartis Investigative Site

    Plano, Texas, 75093

  • Novartis Investigative Site

    Poughkeepsie, New York, 12601

  • Novartis Investigative Site

    Providence, Rhode Island, 02903

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Reno, Nevada, 89502

  • Novartis Investigative Site

    Richmond, Indiana, 47374

  • Novartis Investigative Site

    Richmond, Virginia, 23298

  • Novartis Investigative Site

    Rochester, New York, 14621

  • Novartis Investigative Site

    Sacramento, California, 95817-1460

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55101

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55102

  • Novartis Investigative Site

    San Antonio, Texas, 78229

  • Novartis Investigative Site

    San Diego, California, 92123

  • Novartis Investigative Site

    San Marino, California, 91108

  • Novartis Investigative Site

    San Pablo, California, 94806

  • Novartis Investigative Site

    Sarasota, Florida, 34239

  • Novartis Investigative Site

    Slidell, Louisiana, 70458

  • Novartis Investigative Site

    Stanford, California, 94305

  • Novartis Investigative Site

    Staten Island, New York, 10310

  • Novartis Investigative Site

    Tampa, Florida, 33612

  • Novartis Investigative Site

    Tampa, Florida, 34667

  • Novartis Investigative Site

    The Bronx, New York, 10461

  • Novartis Investigative Site

    The Bronx, New York, 10467-2490

  • Novartis Investigative Site

    Toledo, Ohio, 43608

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74104

  • Novartis Investigative Site

    Vero Beach, Florida, 32960

  • Novartis Investigative Site

    Virginia Beach, Virginia, 23454

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20422

  • Novartis Investigative Site

    Wausau, Wisconsin, 54401

  • Novartis Investigative Site

    West Haven, Connecticut, 06516

  • Novartis Investigative Site

    White River Junction, Vermont, 05009

  • Novartis Investigative Site

    Winfield, Illinois, 60190

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27157

  • Novartis Investigative Site

    Winter Haven, Florida, 33881

Other trials in United States

About this study

Official title: 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%).

Being tested
sacubitril/valsartan (LCZ696), Enalapril, sacubitril/valsartan (LCZ696) matching placebo, enalapril matching placebo
Keywords
Acute, Heart Failure, reduced ejection fraction, NTproBNP, Heart failure with reduced ejection fraction (HFREF)
Medical subject headings
Heart Failure

What participants receive

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

  • sacubitril/valsartan (LCZ696)Drug

    Also called LCZ696

    sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

  • EnalaprilDrug

    Enalapril tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.

  • sacubitril/valsartan (LCZ696) matching placeboDrug

    matching placebo of sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.

  • enalapril matching placeboDrug

    enalapril matching placebo tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.

Study groups in NCT02554890
Study groupRoleWhat they receive
sacubitril/valsartan (LCZ696)ExperimentalInitial 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).
Receives: Drug: sacubitril/valsartan (LCZ696); Drug: enalapril matching placebo
EnalaprilActive comparatorInitial 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)
Receives: Drug: Enalapril; Drug: sacubitril/valsartan (LCZ696) matching placebo

What is being measured

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

  1. 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.

    Measured: Baseline, Week 4 and Week 8

Secondary outcomes (8)

  1. 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.

    Measured: 8 weeks of treatment

  2. 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.

    Measured: 8 weeks of treatment

  3. 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.

    Measured: 8 weeks of treatment

  4. 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.

    Measured: Baseline, Week 4/Week 8

  5. 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)

    Measured: Baseline, Week 4 and Week 8

  6. 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).

    Measured: Baseline, Week 4 and Week 8

  7. 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.

    Measured: baseline, Week 4 and Week 8

  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.

    Measured: Baseline, Week 8

Timeline

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

  1. First posted18 Sep 2015 (estimated)
  2. Study start29 Apr 2016
  3. Primary completion29 Jun 2018
  4. Study completion24 Jul 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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
887 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554890
Sponsor's protocol ID
CLCZ696BUS01
Acronym
PIONEER-HF
Status last verified
Sep 2020
First submitted
17 Sep 2015
Last updated
5 Jan 2021
Data monitoring committee
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

  • 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.

    PubMed 29653636

  • 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.

    PubMed 30415601

  • 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.

    PubMed 30955360

  • 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.

    PubMed 31093657

  • 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.

    PubMed 32919915

  • 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.

    PubMed 32854838

  • 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.

    PubMed 32800511

  • 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.

    PubMed 31825471

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sacubitril/valsartan (LCZ696) and Enalapril in people with Acute Heart Failure, run by Novartis Pharmaceuticals at 123 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 9 inclusion and 11 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 123 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 24 Sep 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?

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline (time frame: Baseline, Week 4 and Week 8). 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 NCT02554890, which also lists 8 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 5 Jan 2021.

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