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| ID | Type | Description | Link |
|---|---|---|---|
| 01 |
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Problems recruting patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spironolactone | Drug | 100 mg once daily. Can be reduced to 50 mg a day still maintaining the doubled-blinded status |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle mass | 0 and 12 weeks | |
| QTc interval | 0 and 12 weeks | |
| Magnesium retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik Vilstrup, Proffessor | Univeristy of Aarhus | Principal Investigator |
| Peter Holland-Fischer, MD | University of Aarhus | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine V (gastroenterology and hepatology) | Aarhus | 9000 | Denmark |
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| ID | Term |
|---|---|
| D002310 | Cardiomyopathy, Alcoholic |
| D000437 | Alcoholism |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| 0, 6, and 12 weeks |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |