CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 55 enrolled
Drug / intervention
sacubitril/valsatran +3 moredrug
Likely dose
sacubitril/valsatran 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03300427
NCT03300427Phase 4Completed
CompareCT.gov

Controlled Trial on the Short-term Effects of Sacubitril/Valsartan Therapy on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Patients With NYHA II-III Heart Failure and Reduced Systolic Function Using 11C-acetate Positron Emission Tomography and Echocardiography

Novartis Pharmaceuticals·interventional·Posted Oct 3, 2017·Updated Jan 5, 2024

In Brief

A Phase 4 clinical trial evaluating sacubitril/valsatran, valsartan, and 2 other interventions for Heart Failure. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the efficiency of cardiac work in patients with NYHA II-III heart failure (HF) and reduced systolic function using 11C-acetate positron emission tomography (PET) and echocardiography.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesFinland
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedOct 3, 2017
Enrollment StartJul 5, 2018
Primary CompletionMar 23, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.7 years ago

Interventions

sacubitril/valsatrandrug

sacubitril/valsatran 100 or 200 mg BID

valsartandrug

Valsartan 80 or 160 mg BID

placebo to valsartandrug

placebo to valsartan 80 or 160 BID

placebo to sacubitril/valsartandrug

placebo to sacubitril/valsartan 100 or 200 mg BID