Alcoholism Clinical Trial
Official title:
Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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