A Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Alagebrium (ALT-711) in Patients With Chronic Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase.
研究概览
简要总结
Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA II-IV heart failure
- •Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction < 40%)
- •Duration of heart failure > 3 months
- •Stable heart failure medical therapy for > 1 month
- •Patients need to be able to understand content of and willing to provide informed consent
排除标准
- •Patient ≤ 18 years
- •History of myocardial infarction in previous 6 months
- •History of stroke/TIA/RIND in previous 6 months
- •Severe valvular dysfunction
- •Severe pulmonary disease
- •History of systemic inflammatory or collagen vascular disease
- •Active and or treated malignancies within 12 months prior to inclusion
- •Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
- •Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
- •Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
- •History of valve replacement or surgery
- •Uncontrolled diabetes mellitus (HbA1c > 9.5%)
- •Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
- •Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)
- •Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)
- •Use of any investigational drug(s) within 30 days prior to screening
- •Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*
- •Active pericarditis/myocarditis
- •The inability of patients to undergo exercise testing
研究组 & 干预措施
ALT-711
Alagebrium 200 mg BID
干预措施: ALT-711 (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary end-point of the study will be aerobic capacity (VO2 max) measured at exercise testing. An improvement of 15% in VO2 max will be considered as a clinically significant increase.
时间窗: 9 months
次要结局
未报告次要终点