NCT00226109

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 26, 2005

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 20, 2010

Status Verified

October 1, 2010

Enrollment Period

7.3 years

First QC Date

September 23, 2005

Last Update Submit

October 19, 2010

Conditions

Cardiomyopathy, AlcoholicAlcoholism

Keywords

Alcoholismcardiomyopathyskeletal musclespironolactoneNa,K-pumpsMagnesium

Outcome Measures

Primary Outcomes (7)

  • Muscle strength

    0 and 12 weeks

  • Muscle endurance

    At 0 and 12 weeks

  • Content of Na,K-pump in skeletal muscle

    0 and 12 weeks

  • Content of sodium and potassium in skeletal muscle

    0 and 12 weeks

  • Steptest result

    0 and 12 weeks

  • Diastolic heart function

    0 and 12 weeks

  • Systolic heart function

    0 and 12 weeks

Secondary Outcomes (3)

  • Muscle mass

    0 and 12 weeks

  • QTc interval

    0 and 12 weeks

  • Magnesium retention

    0, 6, and 12 weeks

Study Arms (1)

A

ACTIVE COMPARATOR
Drug: spironolactone

Interventions

spironolactoneDRUG

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

Also known as: Spirix, Spiron
A

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Alcoholism, male gender

You may not qualify if:

  • Spironolactone treatment
  • Tense ascites
  • Hepatic encephalopathy
  • Dementia
  • Cancer
  • Severe psychiatric disease
  • Untreated thyroid disease
  • Maltreated diabetes
  • Spironolactone contraindications
  • Kidney failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine V (gastroenterology and hepatology)

Aarhus, 9000, Denmark

Location

MeSH Terms

Conditions

Cardiomyopathy, AlcoholicAlcoholismCardiomyopathies

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Hendrik Vilstrup, Proffessor

    Univeristy of Aarhus

    PRINCIPAL INVESTIGATOR

  • Peter Holland-Fischer, MD

    University of Aarhus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 23, 2005

First Posted

September 26, 2005

Study Start

April 1, 2004

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

October 20, 2010

Record last verified: 2010-10

Locations

DK(1)