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

October 19, 2010 updated by: University of Aarhus

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 9000
        • Department of Medicine V (gastroenterology and hepatology)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Drug: spironolactone
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
Other Names:
  • Spirix
  • Spiron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle strength
Time Frame: 0 and 12 weeks
0 and 12 weeks
Muscle endurance
Time Frame: At 0 and 12 weeks
At 0 and 12 weeks
Content of Na,K-pump in skeletal muscle
Time Frame: 0 and 12 weeks
0 and 12 weeks
Content of sodium and potassium in skeletal muscle
Time Frame: 0 and 12 weeks
0 and 12 weeks
Steptest result
Time Frame: 0 and 12 weeks
0 and 12 weeks
Diastolic heart function
Time Frame: 0 and 12 weeks
0 and 12 weeks
Systolic heart function
Time Frame: 0 and 12 weeks
0 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle mass
Time Frame: 0 and 12 weeks
0 and 12 weeks
QTc interval
Time Frame: 0 and 12 weeks
0 and 12 weeks
Magnesium retention
Time Frame: 0, 6, and 12 weeks
0, 6, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 26, 2005

Study Record Updates

Last Update Posted (Estimate)

October 20, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFDV01
  • 01 (Miami VAHS)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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