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

NCT02554890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 887

Last updated 2021-01-05

Study results available
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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%).

Conditions

  • Acute Heart Failure

Interventions

DRUG

sacubitril/valsartan (LCZ696)

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

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.

DRUG

enalapril matching placebo

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-29
Primary Completion
2018-06-29
Completion
2018-07-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554890 on ClinicalTrials.gov