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

niversity Hospital of South Manchester NHS Foundation Trust0 sites94 target enrollmentJanuary 11, 2017

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Specialty: Cardiovascular disease, Primary sub-specialty: Heart Failure
Sponsor: niversity Hospital of South Manchester NHS Foundation Trust
Enrollment: 94
Status: Completed
Last Updated: 4 years ago

2021 Results article in https://doi.org/10.1038/s41591-021-01452-0 (added 31/08/2021)

Registry

who.int

Start Date

January 11, 2017

End Date

April 7, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospital of South Manchester NHS Foundation Trust

•1\. Written informed consent
•2\. Male or female; aged 40 years or older
•3\. HF, defined as one symptom (dyspnoea on exertion,orthopnoea or paroxysmal nocturnal dyspnoea) present at the time of screening, and one sign (peripheral oedema, crackles on chest auscultation post\-cough, raised jugular venous pressure or chest x\-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly) present at the time of screening or in the previous 12 months
•4\. LVEF \> 45% at Visit 0
•5\. BNP \= 100 pg/ml or NTproBNP \= 300 pg/ml at Visit 0\. For patients in atrial fibrillation on Visit 0 ECG, BNP \> 300pg/ml or NTproBNP \> 900 pg/ml at Visit 0
•In order to be randomised, patients must also have myocardial fibrosis, defined as ECM volume \> 27% by CMR at Visit 0\.

•1\. Myocardial infarction, coronary artery bypass graft surgery or percutaneous coronary intervention within the previous 6 months.
•2\. Probable alternative cause of patient’s HF symptoms that in the opinion of the investigator primarily accounts for patient’s dyspnoea such as significant pulmonary disease, anaemia or obesity. Specifically, patients with the below are excluded:
•2\.1\. Severe chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebuliser therapy,or chronic oral steroid therapy), or
•2\.2\. Haemoglobin \< 9 g/dl, or
•2\.3\. Body mass index (BMI) \> 55 kg/m2
•3\. Known pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy
•4\. Clinically significant congenital heart disease
•5\. Presence of severe valvular heart disease
•6\. Atrial fibrillation or flutter with a resting ventricular rate \> 100bpm
•7\. Any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study