EUCTR2016-002647-42-GB进行中（未招募）1 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. - PIROUETTE
niversity Hospital of South Manchester0 个研究点开始时间: 2016年9月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •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.
- •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 <35 mL/min (using CKD-EPI calculation), 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 within 28 days of Visit 0.
- •14.Contraindication to MRI scanning or gadolinium-based contrast agent
- •15.Pregnancy, lactation or planning pregnancy. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment, must agree to pregnancy tests at study visits as defined in the Section 7.2.5 and must agree to maintain highly effective contraception during the study and for 3 months thereafter. Similarly male participants with female partners of childbearing potential must agree to maintain highly effective contraception during the study and for 3 months thereafter.
研究者
相似试验
进行中（未招募）
1 期
A phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in adults with moderate to severe atopic dermatitis. ECZTRA 3 (ECZema TRAlokinumab trial no. 3)Atopic DermatitisEUCTR2017-002065-21-BEEO Pharma A/S369
已完成
2 期
The study of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilatioCTRI/2020/06/026192Vicore Pharma AB106
进行中（未招募）
1 期
A phase 3 trial to evaluate the efficacy and safety of tralokinumab in adults with moderate to severe atopic dermatitis (ECZTRA 2)Atopic DermatitisEUCTR2016-004201-13-PLEO Pharma A/S780
进行中（未招募）
1 期
A phase 3 trial to evaluate the efficacy and safety of tralokinumab in combination with topical corticosteroid in adults with moderate to severe atopic dermatitis. ECZTRA 3 (ECZema TRAlokinumab trial no. 3)MedDRA version: 20.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858Atopic DermatitisEUCTR2017-002065-21-NLEO Pharma A/S380
进行中（未招募）
1 期
A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaEUCTR2017-003458-18-SEIntegrative Research Laboratories AB (IRLAB)74