Alcoholism, Cardiomyopathy, Alcoholic
Conditions
Keywords
Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium
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.
Interventions
DRUGspironolactone
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systolic heart function | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| QTc interval | 0 and 12 weeks |
| Magnesium retention | 0, 6, and 12 weeks |
| Muscle mass | 0 and 12 weeks |
Countries
Denmark
Outcome results
None listed