Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics (SPICA)
Status and phase
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Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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