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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)
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00226109
First received: September 23, 2005
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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
Alcoholism
 Drug: spironolactone
 Phase 4

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Muscle strength [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Muscle endurance [ Time Frame: At 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Content of Na,K-pump in skeletal muscle [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: Yes ]
  • Content of sodium and potassium in skeletal muscle [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Steptest result [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Diastolic heart function [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Systolic heart function [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle mass [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • QTc interval [ Time Frame: 0 and 12 weeks ] [ Designated as safety issue: No ]
  • Magnesium retention [ Time Frame: 0, 6, and 12 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226109

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

No publications provided

Responsible Party: Peter Holland-Fischer, Department of Medicine V, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00226109     History of Changes
Other Study ID Numbers: AFDV01, 01
Study First Received: September 23, 2005
Last Updated: October 19, 2010
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Alcoholism
cardiomyopathy
skeletal muscle
 spironolactone
Na,K-pumps
Magnesium

Additional relevant MeSH terms:
Alcoholism
Cardiomyopathy, Alcoholic
Cardiomyopathies
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Heart Diseases
Cardiovascular Diseases
Alcohol-Induced Disorders
Spironolactone
 Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013