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

Alcoholism Clinical Trial

— SPICA  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00226109
• Other study ID #: AFDV01
• Secondary ID: 01
• Status: Suspended
• Phase: Phase 4
• First received: September 23, 2005
• Last updated: October 19, 2010
• Start date: April 2004
• Est. completion date: December 2011

Study information

• Verified date: October 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: December 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Cardiomyopathies
• Cardiomyopathy, Alcoholic

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Medicine V (gastroenterology and hepatology)	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength		0 and 12 weeks	No
Primary	Muscle endurance		At 0 and 12 weeks	No
Primary	Content of Na,K-pump in skeletal muscle		0 and 12 weeks	Yes
Primary	Content of sodium and potassium in skeletal muscle		0 and 12 weeks	No
Primary	Steptest result		0 and 12 weeks	No
Primary	Diastolic heart function		0 and 12 weeks	No
Primary	Systolic heart function		0 and 12 weeks	No
Secondary	Muscle mass		0 and 12 weeks	No
Secondary	QTc interval		0 and 12 weeks	No
Secondary	Magnesium retention		0, 6, and 12 weeks	No