Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?
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|ClinicalTrials.gov Identifier: NCT00291720|
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : May 21, 2008
Patients with kidney failure have a poor survival rate that is due to a much higher than average rate of heart and vascular disease. The reason that kidney failure causes heart disease is unknown but recent research suggests that a hormone called aldosterone, which is increased in patients with kidney disease may damage the heart and blood vessels.
The investigators propose, using a randomized blinded trial, to find out whether drugs that inhibit the actions of aldosterone have beneficial effects on the cardiovascular system in patients with kidney failure
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Cardiovascular Disease||Drug: Spironolactone Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: Spironolactone
25mg spironolactone daily
All patients receive a 4 week open labeled run in phase of 25mg spironolactone daily after which they are randomized to continue or receive matched placebo for 8 months.
Placebo Comparator: Placebo
matching placebo medication for the control group
- Changes in left ventricular mass on cardiac MRI and arterial stiffness (assessed by pulse wave velocity). [ Time Frame: 9 months ]
- Changes in aortic distensibility and large vessel augmentation [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291720
|University Hospital Birmingham|
|Birmingham, West Midlands, United Kingdom, B15 2TH|
|Principal Investigator:||John N Townend, BSc, MB ChB, MD, FRCP, FESC||University Hospital Birmingham|