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

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ClinicalTrials.gov Identifier: NCT00226109
Recruitment Status : Suspended (Problems recruting patients)
First Posted : September 26, 2005
Last Update Posted : October 20, 2010
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Cardiomyopathy, Alcoholic Alcoholism Drug: spironolactone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
Study Start Date : April 2004
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Muscle strength [ Time Frame: 0 and 12 weeks ]
  2. Muscle endurance [ Time Frame: At 0 and 12 weeks ]
  3. Content of Na,K-pump in skeletal muscle [ Time Frame: 0 and 12 weeks ]
  4. Content of sodium and potassium in skeletal muscle [ Time Frame: 0 and 12 weeks ]
  5. Steptest result [ Time Frame: 0 and 12 weeks ]
  6. Diastolic heart function [ Time Frame: 0 and 12 weeks ]
  7. Systolic heart function [ Time Frame: 0 and 12 weeks ]

Secondary Outcome Measures :
  1. Muscle mass [ Time Frame: 0 and 12 weeks ]
  2. QTc interval [ Time Frame: 0 and 12 weeks ]
  3. Magnesium retention [ Time Frame: 0, 6, and 12 weeks ]

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Peter Holland-Fischer, Department of Medicine V, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00226109     History of Changes
Other Study ID Numbers: AFDV01
First Posted: September 26, 2005    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 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