Back to results

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

Primary Purpose

Acute Heart Failure

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

sacubitril/valsartan (LCZ696)

Enalapril

sacubitril/valsartan (LCZ696) matching placebo

enalapril matching placebo

About this trial

This is an interventional supportive care trial for Acute Heart Failure focused on measuring Acute, Heart Failure, reduced ejection fraction, NTproBNP, Heart failure with reduced ejection fraction (HFREF)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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
- 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.

Key Exclusion Criteria:

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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

sacubitril/valsartan (LCZ696)

Enalapril

Arm Description

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).

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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)

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).

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.

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.

Full Information

NCT ID

NCT02554890

First Posted

September 17, 2015

Last Updated

December 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02554890

Brief Title

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

Acronym

PIONEER-HF

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).

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 29, 2016 (Actual)

Primary Completion Date

June 29, 2018 (Actual)

Study Completion Date

July 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 ventricular ejection fraction (LVEF) ≤ 40%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Heart Failure

Keywords

Acute, Heart Failure, reduced ejection fraction, NTproBNP, Heart failure with reduced ejection fraction (HFREF)

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

887 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sacubitril/valsartan (LCZ696)

Arm Type

Experimental

Arm Description

Arm Title

Enalapril

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

sacubitril/valsartan (LCZ696)

Other Intervention Name(s)

LCZ696

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Enalapril

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

sacubitril/valsartan (LCZ696) matching placebo

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

enalapril matching placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Time-averaged Change From Baseline

Description

Time Frame

Baseline, Week 4 and Week 8

Secondary Outcome Measure Information:

Title

Number of Patients With Incidences of Symptomatic Hypotension

Description

Time Frame

8 weeks of treatment

Title

Number of Patients With Incidences of Hyperkalemia

Description

Time Frame

8 weeks of treatment

Title

Number of Patients With Incidences of Angioedema

Description

Time Frame

8 weeks of treatment

Title

Change From Baseline in High Sensitivity Troponin (Hs-Troponin)

Description

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.

Time Frame

Baseline, Week 4/Week 8

Title

Change From Baseline in Urinary cGMP

Description

Time Frame

Baseline, Week 4 and Week 8

Title

Change From Baseline in Urinary cGMP to Urinary Creatinine Ratio

Description

Time Frame

Baseline, Week 4 and Week 8

Title

Change From Baseline in BNP to NTproBNP Ratio

Description

Time Frame

baseline, Week 4 and Week 8

Title

N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Values and Change From Baseline at Week 8

Description

Time Frame

Baseline, Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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 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. Key Exclusion Criteria: 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. 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.

Facility Information:

Facility Name

Novartis Investigative Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72901

Country

United States

Facility Name

Novartis Investigative Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Novartis Investigative Site

City

Bakersfield

State/Province

California

ZIP/Postal Code

93301

Country

United States

Facility Name

Novartis Investigative Site

City

Fresno

State/Province

California

ZIP/Postal Code

93701

Country

United States

Facility Name

Novartis Investigative Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Novartis Investigative Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90073

Country

United States

Facility Name

Novartis Investigative Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Novartis Investigative Site

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Novartis Investigative Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95817-1460

Country

United States

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Novartis Investigative Site

City

San Marino

State/Province

California

ZIP/Postal Code

91108

Country

United States

Facility Name

Novartis Investigative Site

City

San Pablo

State/Province

California

ZIP/Postal Code

94806

Country

United States

Facility Name

Novartis Investigative Site

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Facility Name

Novartis Investigative Site

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Novartis Investigative Site

City

Littleton

State/Province

Colorado

ZIP/Postal Code

80120

Country

United States

Facility Name

Novartis Investigative Site

City

Bridgeport

State/Province

Connecticut

ZIP/Postal Code

06610

Country

United States

Facility Name

Novartis Investigative Site

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Facility Name

Novartis Investigative Site

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

Novartis Investigative Site

City

West Haven

State/Province

Connecticut

ZIP/Postal Code

06516

Country

United States

Facility Name

Novartis Investigative Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20422

Country

United States

Facility Name

Novartis Investigative Site

City

Atlantis

State/Province

Florida

ZIP/Postal Code

33462

Country

United States

Facility Name

Novartis Investigative Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Novartis Investigative Site

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32608

Country

United States

Facility Name

Novartis Investigative Site

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Novartis Investigative Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209-6511

Country

United States

Facility Name

Novartis Investigative Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Novartis Investigative Site

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Novartis Investigative Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Novartis Investigative Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

34667

Country

United States

Facility Name

Novartis Investigative Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Novartis Investigative Site

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33881

Country

United States

Facility Name

Novartis Investigative Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30901

Country

United States

Facility Name

Novartis Investigative Site

City

Macon

State/Province

Georgia

ZIP/Postal Code

31201

Country

United States

Facility Name

Novartis Investigative Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Novartis Investigative Site

City

Boise

State/Province

Idaho

ZIP/Postal Code

83702

Country

United States

Facility Name

Novartis Investigative Site

City

Aurora

State/Province

Illinois

ZIP/Postal Code

60504

Country

United States

Facility Name

Novartis Investigative Site

City

Elk Grove Village

State/Province

Illinois

ZIP/Postal Code

60007

Country

United States

Facility Name

Novartis Investigative Site

City

Oakbrook Terrace

State/Province

Illinois

ZIP/Postal Code

60181

Country

United States

Facility Name

Novartis Investigative Site

City

Park Ridge

State/Province

Illinois

ZIP/Postal Code

60068

Country

United States

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61606

Country

United States

Facility Name

Novartis Investigative Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61614

Country

United States

Facility Name

Novartis Investigative Site

City

Winfield

State/Province

Illinois

ZIP/Postal Code

60190

Country

United States

Facility Name

Novartis Investigative Site

City

Elkhart

State/Province

Indiana

ZIP/Postal Code

46514

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Novartis Investigative Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Novartis Investigative Site

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303-3400

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Indiana

ZIP/Postal Code

47374

Country

United States

Facility Name

Novartis Investigative Site

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66103

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40205

Country

United States

Facility Name

Novartis Investigative Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40245

Country

United States

Facility Name

Novartis Investigative Site

City

Alexandria

State/Province

Louisiana

ZIP/Postal Code

71301

Country

United States

Facility Name

Novartis Investigative Site

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70808

Country

United States

Facility Name

Novartis Investigative Site

City

Slidell

State/Province

Louisiana

ZIP/Postal Code

70458

Country

United States

Facility Name

Novartis Investigative Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Novartis Investigative Site

City

Annapolis

State/Province

Maryland

ZIP/Postal Code

21401

Country

United States

Facility Name

Novartis Investigative Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Novartis Investigative Site

City

Boston

State/Province

Massachusetts

Country

United States

Facility Name

Novartis Investigative Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Novartis Investigative Site

City

Bay City

State/Province

Michigan

ZIP/Postal Code

48708

Country

United States

Facility Name

Novartis Investigative Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Novartis Investigative Site

City

Maplewood

State/Province

Minnesota

ZIP/Postal Code

55109

Country

United States

Facility Name

Novartis Investigative Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55101

Country

United States

Facility Name

Novartis Investigative Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55102

Country

United States

Facility Name

Novartis Investigative Site

City

Hattiesburg

State/Province

Mississippi

ZIP/Postal Code

39401

Country

United States

Facility Name

Novartis Investigative Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Novartis Investigative Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Novartis Investigative Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Novartis Investigative Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Novartis Investigative Site

City

Camden

State/Province

New Jersey

ZIP/Postal Code

08103-3117

Country

United States

Facility Name

Novartis Investigative Site

City

Elmer

State/Province

New Jersey

ZIP/Postal Code

08318

Country

United States

Facility Name

Novartis Investigative Site

City

Haddon Heights

State/Province

New Jersey

ZIP/Postal Code

08035

Country

United States

Facility Name

Novartis Investigative Site

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07102

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Novartis Investigative Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467-2490

Country

United States

Facility Name

Novartis Investigative Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

Novartis Investigative Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Novartis Investigative Site

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Facility Name

Novartis Investigative Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Novartis Investigative Site

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Novartis Investigative Site

City

Poughkeepsie

State/Province

New York

ZIP/Postal Code

12601

Country

United States

Facility Name

Novartis Investigative Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14621

Country

United States

Facility Name

Novartis Investigative Site

City

Staten Island

State/Province

New York

ZIP/Postal Code

10310

Country

United States

Facility Name

Novartis Investigative Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Novartis Investigative Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Novartis Investigative Site

City

Grand Forks

State/Province

North Dakota

ZIP/Postal Code

58201

Country

United States

Facility Name

Novartis Investigative Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

Novartis Investigative Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Novartis Investigative Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73122

Country

United States

Facility Name

Novartis Investigative Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Novartis Investigative Site

City

Abington

State/Province

Pennsylvania

ZIP/Postal Code

19001

Country

United States

Facility Name

Novartis Investigative Site

City

Camp Hill

State/Province

Pennsylvania

ZIP/Postal Code

17011

Country

United States

Facility Name

Novartis Investigative Site

City

Natrona Heights

State/Province

Pennsylvania

ZIP/Postal Code

15065

Country

United States

Facility Name

Novartis Investigative Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19102 2293

Country

United States

Facility Name

Novartis Investigative Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Novartis Investigative Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29403

Country

United States

Facility Name

Novartis Investigative Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Novartis Investigative Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Novartis Investigative Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37212

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75204

Country

United States

Facility Name

Novartis Investigative Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75093

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Novartis Investigative Site

City

White River Junction

State/Province

Vermont

ZIP/Postal Code

05009

Country

United States

Facility Name

Novartis Investigative Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908

Country

United States

Facility Name

Novartis Investigative Site

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

Facility Name

Novartis Investigative Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Novartis Investigative Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

Novartis Investigative Site

City

Clarksburg

State/Province

West Virginia

ZIP/Postal Code

26301

Country

United States

Facility Name

Novartis Investigative Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792-1615

Country

United States

Facility Name

Novartis Investigative Site

City

Wausau

State/Province

Wisconsin

ZIP/Postal Code

54401

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

29653636

Citation

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.

Results Reference

background

PubMed Identifier

30415601

Citation

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.

Results Reference

background

PubMed Identifier

30955360

Citation

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.

Results Reference

background

PubMed Identifier

31093657

Citation

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.

Results Reference

background

PubMed Identifier

32919915

Citation

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.

Results Reference

derived

PubMed Identifier

32854838

Citation

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.

Results Reference

derived

PubMed Identifier

32800511

Citation

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.

Results Reference

derived

PubMed Identifier

31825471

Citation

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.

Results Reference

derived

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=338

Description

A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Acute Heart Failure

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial