Clinical trial NCT00226109: Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics
Official title: Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Cardiomyopathy, Alcoholic
Alcoholism
Keywords: Alcoholism
cardiomyopathy
skeletal muscle
spironolactone
Na,K-pumps
Magnesium
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-09-26
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Muscle strength
timeFrame: 0 and 12 weeks
measure: Muscle endurance
timeFrame: At 0 and 12 weeks
measure: Content of Na,K-pump in skeletal muscle
timeFrame: 0 and 12 weeks
measure: Content of sodium and potassium in skeletal muscle
timeFrame: 0 and 12 weeks
measure: Steptest result
timeFrame: 0 and 12 weeks
measure: Diastolic heart function
timeFrame: 0 and 12 weeks
measure: Systolic heart function
timeFrame: 0 and 12 weeks
Secondary outcomes:
measure: Muscle mass
timeFrame: 0 and 12 weeks
measure: QTc interval
timeFrame: 0 and 12 weeks
measure: Magnesium retention
timeFrame: 0, 6, and 12 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Medicine V (gastroenterology and hepatology)
Study officials:
affiliation: Univeristy of Aarhus
name: Hendrik Vilstrup, Proffessor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Aarhus
name: Peter Holland-Fischer, MD
role: STUDY_DIRECTOR
References: