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

Verified by: University of Aarhus, October 2010
First Received: September 23, 2005 | Last Updated: October 19, 2010 | Phase: Phase 4 | Start Date: April 2004
Overall Status: Suspended | Estimated Enrollment: 40
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: August 2011

Detailed Clinical Trial 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.

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: University of Aarhus Other

Overall Clinical Trial Officials and Contacts

Hendrik Vilstrup, Proffessor Principal Investigator Univeristy of Aarhus  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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