Official Title: “Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics”

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.

Study Type: Interventional

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

Study Primary Completion Date: August 2008

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.

Intervention(s) in this Clinical Trial

• Drug: spironolactone
  • 100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A

Primary Measures

• Muscle strength
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• Muscle endurance
  • Time Frame: At 0 and 12 weeks
    Safety Issue?: No
• Content of Na,K-pump in skeletal muscle
  • Time Frame: 0 and 12 weeks
    Safety Issue?: Yes
• Content of sodium and potassium in skeletal muscle
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• Steptest result
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• Diastolic heart function
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• Systolic heart function
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No

Secondary Measures

• Muscle mass
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• QTc interval
  • Time Frame: 0 and 12 weeks
    Safety Issue?: No
• Magnesium retention
  • Time Frame: 0, 6, and 12 weeks
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Aarhus

Overall Clinical Trial Officials and Contacts

Hendrik Vilstrup, Proffessor Principal Investigator Univeristy of Aarhus  

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

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00226109

Study ID Number: AFDV01

ClinicalTrials.gov Identifier: NCT00226109

Health Authority: Denmark: Danish Medicines Agency