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

Tracking Information

First Received Date ^ICMJE

September 23, 2005

Last Updated Date

September 1, 2008

Start Date ^ICMJE

April 2004

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Muscle strenght
muscle endurance
content of Na,K-pump in skeletal muscle
content of sodium and potassium in skeletal muscle
steptest result
diastolic heart function
systolic heart function

Change History

Complete list of historical versions of study NCT00226109 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Muscle-mass (dry lean body mass)
QTc inteval (ECG)
s-BNP (Brain Natriuretic Peptide)
s-procollagen III
s- sodium
s-potassium
s-magnesium

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Cardiomyopathy, Alcoholic
Alcoholism

Intervention ^ICMJE

Drug: spironolactone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Estimated Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Holland-Fischer, MD

+45 24212428

phf@svf.au.dk

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00226109

Responsible Party

Peter Holland-Fischer, Department of Medicine V, Aarhus University Hospital

Study ID Numbers ^ICMJE

AFDV01, 01

Study Sponsor ^ICMJE

University of Aarhus

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Hendrik Vilstrup, Proffessor	Univeristy of Aarhus
Study Director:	Peter Holland-Fischer, MD	University of Aarhus

Information Provided By

University of Aarhus

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP