CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 129 enrolled
Drug / intervention
Pirfenidone +1 moredrug
Likely dose
Not stated in 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/NCT02932566
NCT02932566Phase 2Completed
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A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PIROUETTE)

Manchester University NHS Foundation Trust·interventional·Posted Oct 13, 2016·Updated Jul 2, 2020

In Brief

A Phase 2 clinical trial evaluating Pirfenidone and Placebo for Cardiac Failure. Completed, enrolled 129 participants across 1 site.

Detailed Summary

This randomised, double-blind, placebo-controlled, phase 2 study aims to evaluate the efficacy and safety of the anti-fibrotic drug pirfenidone in the treatment of patients with heart failure and preserved left ventricular ejection fraction (HFpEF). Participants will be randomised to receive either pirfenidone or placebo, for a period of 12 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Failure
CountriesUnited Kingdom
CollaboratorsNational Institute for Health Research, United Kingdom, University of Manchester, University of Liverpool, Hoffmann-La Roche

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 13, 2016
Enrollment StartMar 2, 2017
Primary CompletionNov 29, 2019
Study CompletionApr 29, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.7 years ago

Interventions

Pirfenidonedrug

Pirfenidone is an orally bioavailable, small molecule antifibrotic agent.

Placebodrug

Placebo capsule, manufactured with the exact components of the Pirfenidone capsules, without the active ingredient / investigational medicinal product