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

This study has suspended participant recruitment.
(Problems recruting patients)
Information provided by:
University of Aarhus Identifier:
First received: September 23, 2005
Last updated: October 19, 2010
Last verified: October 2010
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.

Condition Intervention Phase
Cardiomyopathy, Alcoholic
Drug: spironolactone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: April 2004
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: spironolactone
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Other Names:
  • Spirix
  • Spiron

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.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00226109

Department of Medicine V (gastroenterology and hepatology)
Aarhus, Denmark, 9000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Hendrik Vilstrup, Proffessor Univeristy of Aarhus
Study Director: Peter Holland-Fischer, MD University of Aarhus
  More Information

Responsible Party: Peter Holland-Fischer, Department of Medicine V, Aarhus University Hospital Identifier: NCT00226109     History of Changes
Other Study ID Numbers: AFDV01
Study First Received: September 23, 2005
Last Updated: October 19, 2010

Keywords provided by University of Aarhus:
skeletal muscle

Additional relevant MeSH terms:
Cardiomyopathy, Alcoholic
Heart Diseases
Cardiovascular Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol-Induced Disorders
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on April 28, 2017