Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?
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
|Chronic Kidney Disease Cardiovascular Disease||Drug: Spironolactone Drug: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?|
- 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 ]
|Study Start Date:||April 2005|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: 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|