Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics

Condition(s) targeted: Cardiomyopathy, Alcoholic; Alcoholism

Intervention: spironolactone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Aarhus

Official(s) and/or principal investigator(s):
Hendrik Vilstrup, Proffessor, Principal Investigator, Affiliation: Univeristy of Aarhus
Peter Holland-Fischer, MD, Study Director, Affiliation: University of Aarhus

Overall contact:
Peter Holland-Fischer, MD, Phone: +45 24212428, Email: phf@svf.au.dk

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.

Official title: Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome:

Muscle strength

Muscle endurance

Content of Na,K-pump in skeletal muscle

Content of sodium and potassium in skeletal muscle

Steptest result

Diastolic heart function

Systolic heart function

Secondary outcome:

Muscle mass

QTc interval

Magnesium retention

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.

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

Peter Holland-Fischer, MD, Phone: +45 24212428, Email: phf@svf.au.dk

Department of Medicine V (gastroenterology and hepatology), Aarhus 9000, Denmark; Recruiting
Peter Holland-Fischer, MD, Phone: +45 24212428, Email: phf@svf.au.dk
Peter Holland-Fischer, MD, Principal Investigator
Niels K. Aagaard, Ph.D., MD, Sub-Investigator

Starting date: April 2004
Ending date: December 2008
Last updated: September 1, 2008