Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics

Conditions
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Cardiomyopathy, Alcoholic, Alcoholism

Intervention / Treatment
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* Drug: spironolactone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Alcoholism, male gender Exclusion Criteria: Spironolactone treatment Tense ascites Hepatic encephalopathy Dementia Cancer Severe psychiatric disease Untreated thyroid disease Maltreated diabetes Spironolactone contraindications Kidney failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: spironolactone<br>* 100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status<br>* Other names: Spiron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength |  | 0 and 12 weeks | 
| Muscle endurance |  | At 0 and 12 weeks | 
| Content of Na,K-pump in skeletal muscle |  | 0 and 12 weeks | 
| Content of sodium and potassium in skeletal muscle |  | 0 and 12 weeks | 
| Steptest result |  | 0 and 12 weeks | 
| Diastolic heart function |  | 0 and 12 weeks | 
| Systolic heart function |  | 0 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass |  | 0 and 12 weeks | 
| QTc interval |  | 0 and 12 weeks | 
| Magnesium retention |  | 0, 6, and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium