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Sponsors and Collaborators: |
University Hospital Birmingham British Heart Foundation |
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Information provided by: | University Hospital Birmingham |
ClinicalTrials.gov Identifier: | NCT00291720 |
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 | Intervention | Phase |
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Chronic Kidney Disease Cardiovascular Disease |
Drug: Spironolactone Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure? |
Enrollment: | 120 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Spironolactone: Active Comparator
25mg spironolactone daily
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Drug: Spironolactone
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.
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Placebo: Placebo Comparator
matching placebo medication for the control group
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Drug: Placebo
matching placebo
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, West Midlands | |
University Hospital Birmingham | |
Birmingham, West Midlands, United Kingdom, B15 2TH |
Principal Investigator: | John N Townend, BSc, MB ChB, MD, FRCP, FESC | University Hospital Birmingham |
Responsible Party: | University Hospital Birmingham ( Research & Development Office ) |
Study ID Numbers: | RPK2749, 04/Q2707/294 |
Study First Received: | February 13, 2006 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00291720 |
Health Authority: | United Kingdom: Research Ethics Committee |
Aldosterone Spironolactone Chronic Kidney Disease Arterial Stiffness |
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic |
Kidney Diseases Spironolactone Kidney Failure |
Aldosterone Antagonists Natriuretic Agents Therapeutic Uses Hormone Antagonists Physiological Effects of Drugs |
Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |