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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Department of Medicine V (gastroenterology and hepatology)
Aarhus, Denmark
Muscle strength
Time frame: 0 and 12 weeks
Muscle endurance
Time frame: At 0 and 12 weeks
Content of Na,K-pump in skeletal muscle
Time frame: 0 and 12 weeks
Content of sodium and potassium in skeletal muscle
Time frame: 0 and 12 weeks
Steptest result
Time frame: 0 and 12 weeks
Diastolic heart function
Time frame: 0 and 12 weeks
Systolic heart function
Time frame: 0 and 12 weeks
Muscle mass
Time frame: 0 and 12 weeks
QTc interval
Time frame: 0 and 12 weeks
Magnesium retention
Time frame: 0, 6, and 12 weeks
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