ISRCTN91621241已完成2 期
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 个研究点目标入组 94 人开始时间: 2017年1月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 94
研究概览
简要总结
2021 Results article in https://doi.org/10.1038/s41591-021-01452-0 (added 31/08/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •8. Severe renal dysfunction at Visit 0, defined as eGFR <30 mL/min, or end-stage renal disease requiring dialysis
- •9. History of severe hepatic impairment or liver dysfunction at Visit 0, defined as total bilirubin above the ULN (excluding patients with Gilbert’s syndrome), AST or ALT >3 times the ULN or alkaline phosphatase >2.5 times the ULN.
- •10. Prolonged corrected QT interval, defined as a corrected QT interval >500 msec on ECG using Bazett formula
- •11. Known hypersensitivity to any of the components of the IMP
- •12. Use of other investigational drugs at the time of enrolment, or within 30 days or 5 half-lives of enrolment, whichever is longer.
- •13. Fluvoxamine use 28 days prior of Visit 0
- •14. Contraindication to MRI scanning or gadolinium-basedcontrast agent
- •15. Pregnancy, lactation or planning pregnancy
研究者
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