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

Phase 4

Suspended

• Conditions: Cardiomyopathy, Alcoholic; Alcoholism
• Interventions: Drug: spironolactone

• Registration Number: NCT00226109
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-23
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-26
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-20
• Primary Completion: 2011-08
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	spironolactone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Muscle mass	0 and 12 weeks
QTc interval	0 and 12 weeks
Magnesium retention	0, 6, and 12 weeks

Trial Locations

Locations (1)

Department of Medicine V (gastroenterology and hepatology); 🇩🇰 Aarhus, Denmark