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

Primary Purpose

Cardiomyopathy, Alcoholic, Alcoholism

Status
Suspended
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
spironolactone
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiomyopathy, Alcoholic focused on measuring Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine V (gastroenterology and hepatology)

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Muscle strength
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

Secondary Outcome Measures

Muscle mass
QTc interval
Magnesium retention

Full Information

First Posted
September 23, 2005
Last Updated
October 19, 2010
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT00226109
Brief Title
Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics
Acronym
SPICA
Official Title
Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Suspended
Why Stopped
Problems recruting patients
Study Start Date
April 2004 (undefined)
Primary Completion Date
August 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Alcoholic, Alcoholism
Keywords
Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
spironolactone
Other Intervention Name(s)
Spirix, Spiron
Intervention Description
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Primary Outcome Measure Information:
Title
Muscle strength
Time Frame
0 and 12 weeks
Title
Muscle endurance
Time Frame
At 0 and 12 weeks
Title
Content of Na,K-pump in skeletal muscle
Time Frame
0 and 12 weeks
Title
Content of sodium and potassium in skeletal muscle
Time Frame
0 and 12 weeks
Title
Steptest result
Time Frame
0 and 12 weeks
Title
Diastolic heart function
Time Frame
0 and 12 weeks
Title
Systolic heart function
Time Frame
0 and 12 weeks
Secondary Outcome Measure Information:
Title
Muscle mass
Time Frame
0 and 12 weeks
Title
QTc interval
Time Frame
0 and 12 weeks
Title
Magnesium retention
Time Frame
0, 6, and 12 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Vilstrup, Proffessor
Organizational Affiliation
Univeristy of Aarhus
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Holland-Fischer, MD
Organizational Affiliation
University of Aarhus
Official's Role
Study Director
Facility Information:
Facility Name
Department of Medicine V (gastroenterology and hepatology)
City
Aarhus
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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