Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Muscle strength
研究概览
简要总结
Chronic alcoholics suffer from weak skeletal and cardiac muscle. The investigators have discovered a beneficial effect of spironolactone-treatment in that regard. Therefore, a double blind placebo controlled study is conducted, to examine the effects of spironolactone on cardiac and skeletal muscle-function in chronic alcoholics.
详细描述
Our department has done research into skeletal muscle function in patients with liver cirrhosis. Post-hoc analyses of one of these studies suggested that treatment with spironolactone had a positive effect on muscle strength and endurance. This effect was probably caused by an increase in concentration of Na, K-pumps (sodium-potassium pumps) enabling the muscle cell perform better.
To verify this finding we have designed a double-blinded, placebo-controlled, randomized clinical trial with skeletal muscle strength, -endurance, Na, K-pump content, cardiac systolic, and diastolic function as primary endpoints. Spironolactone is tested against placebo in 40 participants included among our admitted and out-clinic patients. Muscle function-tests, muscle biopsy and trans-thoracic echocardiography is performed before and after 12 weeks of treatment.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Alcoholism, male gender
排除标准
- •Spironolactone treatment
- •Tense ascites
- •Hepatic encephalopathy
- •Severe psychiatric disease
- •Untreated thyroid disease
- •Maltreated diabetes
- •Spironolactone contraindications
- •Kidney failure
研究组 & 干预措施
A
干预措施: spironolactone (Drug)
结局指标
主要结局
Muscle strength
时间窗: 0 and 12 weeks
Muscle endurance
时间窗: At 0 and 12 weeks
Content of Na,K-pump in skeletal muscle
时间窗: 0 and 12 weeks
Content of sodium and potassium in skeletal muscle
时间窗: 0 and 12 weeks
Steptest result
时间窗: 0 and 12 weeks
Diastolic heart function
时间窗: 0 and 12 weeks
Systolic heart function
时间窗: 0 and 12 weeks
次要结局
- Muscle mass(0 and 12 weeks)
- QTc interval(0 and 12 weeks)
- Magnesium retention(0, 6, and 12 weeks)