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Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction

NCT02874794 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2021-01-05

Study results available
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Summary

To determine whether treatment with sacubitril/valsartan provides a superior effect on aortic characteristic impedance compared to enalapril in patients with heart failure and reduced ejection fraction (left ventricular ejection fraction \[LVEF\] ≤ 40%) after 12 weeks of treatment. The primary endpoint is the change in aortic characteristic impedance (Zc = dP/dQ in early systole) between baseline and Week 12.

Conditions

  • Heart Failure and Reduced Ejection Fraction

Interventions

DRUG

LCZ696 (sacubitril/valsartan)

24/26mg, 49/51mg and 97/103mg oral, tablets.

DRUG

Enalapril

2.5mg, 5mg, and 10mg, oral, tablets

DRUG

Placebo of Enalapril

matching placebo (2.5mg, 5mg and 10mg) oral, tablets

DRUG

Placebo of LCZ696

matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-17
Primary Completion
2018-12-13
Completion
2019-01-26

Countries

  • United States

Study Locations

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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 NCT02874794 on ClinicalTrials.gov