A Phase 4 interventional study of spironolactone in Cardiomyopathy, Alcoholic and Alcoholism, sponsored by University of Aarhus. Suspended at 1 site in Denmark. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-10-20.
Sponsored by University of Aarhus · Phase 4, Interventional, and Treatment
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 40 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
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Exclusion Criteria:
Drug: spironolactone
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Also known as: Spirix, Spiron
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
This study is suspended, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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University of Aarhus