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Is Spironolactone Safe and Effective in the Treatment of Cardiovascular Disease in Mild Chronic Renal Failure?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00291720
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : May 21, 2008
British Heart Foundation
Information provided by:
University Hospital Birmingham

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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?
Study Start Date : April 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Failure

Arm Intervention/treatment
Active Comparator: Spironolactone
25mg spironolactone daily
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.

Placebo Comparator: Placebo
matching placebo medication for the control group
Drug: Placebo
matching placebo

Primary Outcome Measures :
  1. Changes in left ventricular mass on cardiac MRI and arterial stiffness (assessed by pulse wave velocity). [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. Changes in aortic distensibility and large vessel augmentation [ Time Frame: 9 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • Diabetes mellitus
  • Clinical evidence of fluid overload or hypovolaemia
  • Recent (< 2 months) acute myocardial infarction
  • Left ventricular (LV) dysfunction (ejection fraction < 40% by echocardiography).

Information from the National Library of Medicine

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 identifier (NCT number): NCT00291720

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United Kingdom
University Hospital Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University Hospital Birmingham
British Heart Foundation
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Principal Investigator: John N Townend, BSc, MB ChB, MD, FRCP, FESC University Hospital Birmingham

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Research & Development Office, University Hospital Birmingham Identifier: NCT00291720    
Other Study ID Numbers: RPK2749
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: May 21, 2008
Last Verified: May 2008
Keywords provided by University Hospital Birmingham:
Chronic Kidney Disease
Arterial Stiffness
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Cardiovascular Diseases
Urologic Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents