NCT02932566: PIROUETTE

The Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction

Completed Phase 2 Last updated 2 July 2020

What this trial tests

Phase 2 trial testing Pirfenidone in Cardiac Failure in 129 participants. Completed in 29 April 2020.

Timeline

2 March 2017

Primary endpoint
29 November 2019

29 April 2020

Quick facts

Lead sponsor	Manchester University NHS Foundation Trust
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	129
Start date	2 March 2017
Primary completion	29 November 2019
Estimated completion	29 April 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Pirfenidone — full drug profile →
• Placebo

Conditions studied

• Cardiac Failure — all drugs for Cardiac Failure →

Sponsor

Manchester University NHS Foundation Trust

Who can join

40 and older, any sex, with Cardiac Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pirfenidone in heart failure with preserved ejection fraction: a randomized phase 2 trial.
   Lewis GA, Dodd S, Clayton D, Bedson E, et al · · 2021 · cited 148× · PMID 34385704 · DOI 10.1038/s41591-021-01452-0
2. Therapeutic Targets for the Treatment of Cardiac Fibrosis and Cancer: Focusing on TGF-β Signaling.
   Parichatikanond W, Luangmonkong T, Mangmool S, Kurose H. · · 2020 · cited 118× · PMID 32211422 · DOI 10.3389/fcvm.2020.00034
3. Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction.
   D'Amario D, Migliaro S, Borovac JA, Restivo A, et al · · 2019 · cited 106× · PMID 31749710 · DOI 10.3389/fphys.2019.01347
4. Therapeutic approaches in heart failure with preserved ejection fraction: past, present, and future.
   Wintrich J, Kindermann I, Ukena C, Selejan S, et al · · 2020 · cited 76× · PMID 32236720 · DOI 10.1007/s00392-020-01633-w
5. Development of antifibrotic therapy for stricturing Crohn's disease: lessons from randomized trials in other fibrotic diseases.
   Lin SN, Mao R, Qian C, Bettenworth D, et al · · 2022 · cited 62× · PMID 34569264 · DOI 10.1152/physrev.00005.2021
6. Pirfenidone in Heart Failure with Preserved Ejection Fraction-Rationale and Design of the PIROUETTE Trial.
   Lewis GA, Schelbert EB, Naish JH, Bedson E, et al · · 2019 · cited 52× · PMID 31069575 · DOI 10.1007/s10557-019-06876-y
7. Post-myocardial infarction fibrosis: Pathophysiology, examination, and intervention.
   Yin X, Yin X, Pan X, Zhang J, et al · · 2023 · cited 50× · PMID 37056987 · DOI 10.3389/fphar.2023.1070973
8. Extracellular matrix remodelling in obesity and metabolic disorders.
   Musale V, Wasserman DH, Kang L. · · 2023 · cited 49× · PMID 37383542 · DOI 10.1093/lifemeta/load021