NCT03491969已完成4 期
Clinical Study of Lipoic Acid on Ischemic Heart Failure
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of Participants That Had First Occurrence of the Composite Endpoint
研究概览
简要总结
The study will evaluate the efficacy of alpha-lipoic acid(α-LA) on mortality in patients with ischemic heart failure (NYHA Class II - IV and EF =< 50%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •patients ≥ 18 years of age, male or female.
- •Patients with a diagnosis of AMI (>30 days) according to the global definition. ③Patients with a diagnosis of CHF (NYHA class II-IV) and reduced ejection fraction (EF =< 50%) and elevated BNP（NT-proBNP≥600pg/ml or BNP≥150pg/ml; NT-proBNP ≥400 pg/mL or BNP ≥100 pg/mL if patients was hospitalized for heart failure within 12months).
- •Patients must be treated with standardized heart failure medications treatment at a stable dose for at least 4 weeks.
- •Patients must give written informed consent before any assessment is performed.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •allergy to any of the study drugs, drugs of similar chemical classes（Vitamin B） as well as known or suspected contraindications to the study drugs.
- •Previous history of intolerance to recommended target doses of α-LA.
- •Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy).
- •⑤ Symptomatic hypotension and/or a SBP < 100 mmHg.
- •⑥ Severe liver function abnormalities (ALT or AST more than 3 times of the normal upper limit).
- •⑦ Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula.
- •⑧ Serum potassium > 5.2 mmol/L.
- •⑨ Pregnant women or women preparing for birth.
研究组 & 干预措施
Placebo
Placebo Comparator
Double blind treatment period consisted of treatment with CHF standard treatments, followed by Placebo 200 mg tid over a total duration of 24 months.
干预措施: Placebos (Drug)
Alpha-Lipoic Acid(α-LA)
Experimental
Double blind treatment period consisted of treatment with CHF standard treatments, followed by α-LA 200 mg tid over a total duration of 24 months.
干预措施: Alpha-Lipoic Acid(α-LA) (Drug)
结局指标
主要结局
Number of Participants That Had First Occurrence of the Composite Endpoint
时间窗: up to 24 months
either all-cause death or heart failure (HF) hospitalization
次要结局
未报告次要终点
研究者
Xu Lei
Doctor
Shanghai Zhongshan Hospital
研究点 (1)
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