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

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00226109

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 IV

MedlinePlus related topics: Alcoholism Cardiomyopathy

Drug Information available for: Magnesium Spironolactone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics

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 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: spironolactone 100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status

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

Contacts

Contact: Peter Holland-Fischer, MD

+45 24212428

phf@svf.au.dk

Locations

Denmark
Department of Medicine V (gastroenterology and hepatology)	Recruiting
Aarhus, Denmark, 9000
Contact: Peter Holland-Fischer, MD +45 24212428 phf@svf.au.dk
Principal Investigator: Peter Holland-Fischer, MD
Sub-Investigator: Niels K. Aagaard, Ph.D., MD

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

Responsible Party:	Department of Medicine V, Aarhus University Hospital ( Peter Holland-Fischer )
Study ID Numbers:	AFDV01, 01
Study First Received:	September 23, 2005
Last Updated:	September 1, 2008
ClinicalTrials.gov Identifier:	NCT00226109
Health Authority:	Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:

Alcoholism
cardiomyopathy
skeletal muscle

spironolactone
Na,K-pumps
Magnesium

Study placed in the following topic categories:

Alcohol-Induced Disorders
Heart Diseases
Mental Disorders
Cardiomyopathy, Alcoholic
Alcoholism

Substance-Related Disorders
Disorders of Environmental Origin
Alcohol-Related Disorders
Cardiomyopathies
Spironolactone

Additional relevant MeSH terms:

Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs

Diuretics
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009