An Exploratory Phase 2 Study to Determine Safety, Tolerability and Impact of BGP-15 on cardiac fibrosis and ventricular remodelling in patients with Non-Ischaemic Dilated Cardiomyopathy (NIDCM)

BakerIDI Heart and Diabetes Institute0 个研究点目标入组 90 人开始时间: 2016年4月13日最近更新: 2020年1月13日

适应症

试验速览

阶段: 2 期
状态: 撤回
发起方
入组人数: 90

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment

入排标准

年龄范围: 18 Years 至 80 Years（—）
性别: All

入选标准

•1.Males aged 18-80 years, inclusive
•2.Females aged 18-80 years inclusive meeting the following criteria:
•- A negative serum pregnancy test at Screening, not breast feeding and did not plan to be pregnant during the study, AND if one of the following three criteria was met:
•-They had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form;
•-They had been postmenopausal for at least 1 year; or,
•-They were of childbearing potential and practiced one of the following methods of birth control throughout the study: injectable or implantable hormonal contraception or intrauterine device; or two of the following methods of birth control throughout the study: oral or patch contraception plus a barrier contraceptive (e.g., diaphragm plus spermicide, male or female condom plus spermicide, or vasectomized male partner).
•3.Known history of non-ischemic dilated cardiomyopathy as determined using appropriate invasive and/or non-invasive imaging assessments
•4.Reduced left ventricular function, with a calculated LVEF between 35-50% based on CMR imaging
•5.Evidence for significant LV dilation defined as > 2SD above the mean LVEDVi value for a gender compared normal population
•6.Evidence of increased interstitial myocardial fibrosis, suggested by a native myocardial T1 time greater than 1218ms.
•7.No evidence for maximum LV wall thickness > 15mm at end-diastole by cardiac magnetic resonance imaging or echocardiography
•8.No evidence for resting LV outflow tract (LVOT) obstruction > 10mmHg at either valvular and/or sub-valvular level
•9.Stable symptoms with no hospital admissions for heart failure in the preceding 3 months
•10.Stable heart failure medical therapy with no changes in medications (other than diuretic dose) in preceding 3 months
•11.Able to perform exercise testing but unable to achieve greater than the lower limit of normal VO2 max (20 mL/kg/min) at visit 2.
•12.Expected life expectancy of at least 2 years.
•13.Have given written informed consent
•14.In the investigator’s opinion, the participant is able and willing to comply with study medication as required by the protocol.

排除标准

•1.Any contraindication to CMR scanning (non-CMR compatible pacemaker, other metallo-prosthetic implant, or severe claustrophobia).
•2.Stage IIIB or worse renal dysfunction (glomerular filtration rate [GFR] <45ml/hour)
•3.Plan for cardiac pacemaker of implantable cardioverter defibrillator (ICD) insertion.
•4.Any severe comorbidity precluding study drug or successful completion of study protocol.
•5.Previous myocardial infarction
•6.Evidence of liver disease defined as aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin >2 x upper limit of normal at Visit 2
•7.History of active malignancy within the past 5 years except for localized prostate cancer treated with hormone therapy, cervical carcinoma, or non-malignant melanoma
•8.History or evidence of drug or alcohol abuse within the last 12 months of Visit 1
•9.Use of other investigational drugs and devices at the time of enrolment, or within 90 days of Visit 1
•10.History of non-compliance to medical regimens or unwillingness to comply with the study protocol
•11.Any condition that in the opinion of the Investigators would confound the evaluation and interpretation of the data
•12.Persons directly involved in the execution of the protocol

研究者

发起方

BakerIDI Heart and Diabetes Institute

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