Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226109
Status:
SUSPENDED
Last Update Posted:
2010-10-20
First Post:
2005-09-23
Brief Title:
Clinical Trial Studying the Effects of Spironolactone on Heart and Skeletal Muscle Function in Chronic Alcoholics
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effect of Spironolactone Treatment on Heart- and Skeletal Muscle in Chronic Alcoholics
Status:
SUSPENDED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Problems recruting patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPICA
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01 | None | None | None |