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

NCT02932566 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2020-07-02

No results posted yet for this study

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.

Conditions

  • Cardiac Failure

Interventions

DRUG

Pirfenidone

Pirfenidone is an orally bioavailable, small molecule antifibrotic agent.

DRUG

Placebo

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

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Manchester

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Manchester University NHS Foundation Trust

    lead OTHER_GOV

Principal Investigators

  • Christopher A Miller, MBChB, PhD · University of Manchester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-02
Primary Completion
2019-11-29
Completion
2020-04-29

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02932566 on ClinicalTrials.gov