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

NCT ID: NCT00226109

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Cardiomyopathy, Alcoholic Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Group Type ACTIVE_COMPARATOR

spironolactone

Intervention Type DRUG

100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status

Interventions

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spironolactone

100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status

Intervention Type DRUG

Other Intervention Names

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Spirix Spiron

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Department of Medicine V, Aarhus University Hospital

Principal Investigators

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Hendrik Vilstrup, Proffessor

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Aarhus

Peter Holland-Fischer, MD

Role: STUDY_DIRECTOR

University of Aarhus

Locations

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Department of Medicine V (gastroenterology and hepatology)

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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01

Identifier Type: -

Identifier Source: secondary_id

AFDV01

Identifier Type: -

Identifier Source: org_study_id