Status:
COMPLETED
Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?
Lead Sponsor:
University Hospital Birmingham
Collaborating Sponsors:
British Heart Foundation
Conditions:
Chronic Kidney Disease
Cardiovascular Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Cardiovascular disease leads to the death of over half of patients with chronic renal failure (CRF) but the causes of this 'vasculopathy' remain unknown. Aldosterone is present in the circulation of r...
Eligibility Criteria
Inclusion
- Mild-moderate chronic kidney disease (glomerular filtration rate \[GFR\] 40-80 mls/min calculated by Cockroft-Gault equation)
- Controlled blood pressure (\< 130/80 mmHg)
- On established (\> 6 weeks) treatment with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
Exclusion
- Diabetes mellitus
- Clinical evidence of fluid overload or hypovolaemia
- Recent (\< 2 months) acute myocardial infarction
- Left ventricular (LV) dysfunction (ejection fraction \< 40% by echocardiography).
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00291720
Start Date
April 1 2005
End Date
December 1 2007
Last Update
May 21 2008
Active Locations (1)
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1
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH