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

niversity Hospital of South Manchester0 sitesSeptember 23, 2016

Overview

No summary available.

Registry

who.int

Start Date

September 23, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital of South Manchester

•Patients eligible for inclusion in this study should fulfil all of the following criteria:
•1\.Written informed consent.
•2\.Male or female; aged 40 years or older.
•3\.HF, defined as one symptom present at the time of screening, and one sign present at the time of screening or in the previous 12 months. Symptoms and signs are defined as:
•Symptoms: dyspnoea on exertion, orthopnoea or paroxysmal nocturnal dyspnoea
•Signs: peripheral oedema, crackles on chest auscultation post\-cough, raised jugular venous pressure or chest x\-ray demonstrating pleural effusion, pulmonary congestion, or cardiomegaly
•4\.LVEF \> 45% at Visit 0, (any local LVEF measurement made using echocardiography or CMR).
•5\.BNP \= 100 pg/ml or NTproBNP \= 300 pg/ml recorded at Visit 0\. For patients in atrial fibrillation on Visit 0 ECG, BNP \> 300pg/ml or NTproBNP \> 900 pg/ml at Visit 0\.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0

•Patients with the following characteristics will be excluded from the trial:
•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:
•a.Severe chronic obstructive pulmonary disease (COPD) (i.e., requiring home oxygen, chronic nebuliser therapy, or chronic oral steroid therapy), or
•b.Haemoglobin \< 9 g/dl, or
•c.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 \> 100 bpm.