Cardiomyopathy, AlcoholicPhase 4SPICANCT00226109
Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics
A Phase 4 study testing spironolactone in people with Cardiomyopathy, Alcoholic and Alcoholism, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Cardiomyopathy, Alcoholic, Alcoholism
- What is being tested?
- spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2004to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Alcoholism, male gender
Who cannot join
- Spironolactone treatment
- Tense ascites
- Hepatic encephalopathy
- Dementia
- Cancer
- Severe psychiatric disease
Show all 10Show fewer
- Untreated thyroid disease
- Maltreated diabetes
- Spironolactone contraindications
- Kidney failure
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine V (gastroenterology and hepatology)
Aarhus, 9000
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiomyopathy, Alcoholic, Alcoholism
- Being tested
- spironolactone
- Keywords
- Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium
- Medical subject headings
- Cardiomyopathy, Alcoholic, Alcoholism, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
Also called Spirix, Spiron
100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Measured: 0 and 12 weeks
Muscle endurance
Measured: At 0 and 12 weeks
Content of Na,K-pump in skeletal muscle
Measured: 0 and 12 weeks
Content of sodium and potassium in skeletal muscle
Measured: 0 and 12 weeks
Steptest result
Measured: 0 and 12 weeks
Diastolic heart function
Measured: 0 and 12 weeks
Systolic heart function
Measured: 0 and 12 weeks
Secondary outcomes (3)
Muscle mass
Measured: 0 and 12 weeks
QTc interval
Measured: 0 and 12 weeks
Magnesium retention
Measured: 0, 6, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Why it stopped: Problems recruting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy, AlcoholicStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Hendrik Vilstrup, Proffessor, Principal investigator, Univeristy of AarhusPeter Holland-Fischer, MD, Study director, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226109
- Sponsor's protocol ID
- AFDV01
- Other IDs
- 01
- Acronym
- SPICA
- Status last verified
- Oct 2010
- First submitted
- 23 Sep 2005
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
- ClinicalTrials.gov ID
- NCT00226109
- Acronym / sponsor ID
- SPICA / AFDV01
- Conditions
- Cardiomyopathy, Alcoholic, Alcoholism
- Keywords
- Alcoholism, cardiomyopathy, skeletal muscle, spironolactone, Na,K-pumps, Magnesium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Problems recruting patients
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Apr 2004
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 26 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: spironolactone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Alcoholism, male gender
Key exclusion criteria (10 listed)
- Spironolactone treatment
- Tense ascites
- Hepatic encephalopathy
- Dementia
- Cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spironolactoneAlso: Spirix, Spiron100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status | Drug | A |
Primary outcome
Muscle strength
Time frame: 0 and 12 weeks
Muscle endurance
Time frame: At 0 and 12 weeks
Content of Na,K-pump in skeletal muscle
Time frame: 0 and 12 weeks
Content of sodium and potassium in skeletal muscle
Time frame: 0 and 12 weeks
Steptest result
Time frame: 0 and 12 weeks
Diastolic heart function
Time frame: 0 and 12 weeks
Systolic heart function
Time frame: 0 and 12 weeks
3 secondary outcomes
Muscle mass
Time frame: 0 and 12 weeks
QTc interval
Time frame: 0 and 12 weeks
Magnesium retention
Time frame: 0, 6, and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Vilstrup, Proffessor principal investigator
Univeristy of Aarhus
Peter Holland-Fischer, MD study director
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spironolactone in people with Cardiomyopathy, Alcoholic and Alcoholism, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 0 and 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.