CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 467 enrolled
Drug / intervention
sacubitril/valsartan +3 moredrug
Likely dose
sacubitril/valsartan 26 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/NCT03988634
NCT03988634Phase 3Completed

A Multicenter, Randomized, Double-blind, Double Dummy, Parallel Group, Active-controlled Study to Evaluate the Effect of Sacubitril/Valsartan (LCZ696) Versus Valsartan on Changes in NT-proBNP, Safety, and Tolerability in HFpEF Patients With a WHF Event (HFpEF Decompensation) Who Have Been Stabilized and Initiated at the Time of or Within 30 Days Post-decompensation (PARAGLIDE-HF)

Novartis Pharmaceuticals·interventional·Posted Jun 17, 2019·Updated Mar 6, 2025

In Brief

A Phase 3 clinical trial evaluating sacubitril/valsartan, valsartan, and 2 other interventions for Heart Failure With Preserved Ejection Fraction (HFpEF). Completed, enrolled 467 participants across 97 sites in 2 countries.

Detailed Summary

The effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in HFpEF patients with a WHF event (HFpEF decompensation) who had been stabilized and initiated at the time of or within 30 days post-decompensation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJun 17, 2019
Enrollment StartJun 29, 2019
Primary CompletionDec 14, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.0 years ago

Interventions

sacubitril/valsartandrug

Sacubitril/valsartan (LCZ696) was available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily

valsartandrug

Valsartan was available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily

sacubitril/valsartan matching placebodrug

Sacubitril/valsartan (LCZ696) matching placebo was available as tablet form to be taken orally, twice daily

valsartan matching placebodrug

Valsartan matching placebo was available as tablet form to be taken orally, twice daily