NCT02316743Unknown4 期
Beneficial Effects of Levothyroxine Supplementation in Patients With Systolic Heart Failure and Subclinical Hypothyroidism
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Performance at the 6 minutes walk test
研究概览
简要总结
The purpose of this study is to determine whether levothyroxine supplementation is beneficial in patients with systolic heart failure and subclinical hypothyroidism on the functional class evaluated with a 6 minute walk test.
详细描述
Forty patients with systolic heart failure and subclinical hypothyroidism will be include in a open label trial. They will receive levothyroxine supplementation to determine if their functional class will be affect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Biochemical diagnosis of subclinical hypothyroidism (TSH between 3.5 and 10 with a normal T4)
- •Systolic heart failure with New-York Heart Association (NYHA) class II or III
- •Left ventricular ejection fraction under 40%
- •Stable heart failure for the past 3 months (no IV furosemide or hospital admission)
- •Beta-blockers and ACE inhibitors titrated to the maximum tolerated dose
排除标准
- •Isolated diastolic heart failure
- •Awaiting cardiac resynchronisation therapy
- •Impossibility to perform the 6 minutes walk test
- •Active cancer / Life expectancy under 18 months
- •Treatment with amiodarone
研究组 & 干预措施
Levothyroxine
Experimental
Levothyroxine supplementation
干预措施: Levothyroxine supplementation (Drug)
结局指标
主要结局
Performance at the 6 minutes walk test
时间窗: 6 months
次要结局
- Difference of activin a measurement(6 months)
- Difference of myostatin measurement(6 months)
- Difference of systolic and diastolic function on transthoracic echocardiogram(6 months)
- Arhythmic (ventricular arrhythmias and supraventricular arrythmias) and ischemic events (myocardial infarction, unstable angina and hospitalization for revascularization)(6 months)
- Normalisation of thyroid workup(6 months)
- Difference of the brain natriuretic peptide measurement(6 months)
- Increase in heart rate measurement(6 months)
研究者
Paul Farand
Investigator
Université de Sherbrooke
研究点 (1)
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