Thiamine Supplementation in Heart Failure Patients Receiving Full Medical Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dyspnea score
研究概览
简要总结
The study is performed to consider the effect of thiamine supplementation on symptoms and signs of patients with heart failure and systolic and diastolic function of left ventricle.
详细描述
The study is performed to consider the effect of thiamine supplementation versus placebo on symptoms and signs of patients with heart failure systolic and diastolic function of left ventricle.
Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%) are randomized to receive tablets of 300mg or placebo for 1 months in a double-blind fashion. All subjects will be on stable optimal medical therapy according to the present guidelines for at least 3 months before enrolment. At randomization and at study end, echocardiography by a single observer will be performed and assessment of symptoms and signs and quality of life based on self scoring system (from 1 to 7) and objective physical examinations will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart failure patients (left ventricular ejection fraction (LVEF ≤ 40%)
- •Optimal medical therapy according to the present guidelines for at least 3 months before enrollment.
排除标准
- •Decompensated heart failure
- •Renal failure
- •Uncontrolled hypertension
- •Bradycardia or tachycardia which needs increase or decrease in medications
研究组 & 干预措施
Thiamine
Thiamine tablets of 300mg are prescribed for 1 months
干预措施: Thiamine (Drug)
Plascebo
Tablets of 300mg placebo are prescribed for 1 months
干预措施: Thiamine (Drug)
结局指标
主要结局
Dyspnea score
时间窗: 30 days
scores are given by the patients from 1 to 7 to dyspnea and are reevaluted after 30 days of intervention
次要结局
- Systolic function(30 days)
- Edema score(30 days)