NCT00226109

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

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

• Status: Suspended
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiomyopathy, Alcoholic
• Alcoholism

Interventions

Type	Name	Description
DRUG	spironolactone	100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status

Timeline

• Start date: 2004-04-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2005-09-26
• Last updated: 2010-10-20

Locations

1 site across 1 country: Denmark