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

This study has been completed.
British Heart Foundation
Information provided by:
University Hospital Birmingham Identifier:
First received: February 13, 2006
Last updated: May 20, 2008
Last verified: May 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 Intervention Phase
Chronic Kidney Disease Cardiovascular Disease Drug: Spironolactone Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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?

Resource links provided by NLM:

Further study details as provided by University Hospital Birmingham:

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

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

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
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

  Show Detailed Description


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00291720

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


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Research & Development Office, University Hospital Birmingham Identifier: NCT00291720     History of Changes
Other Study ID Numbers: RPK2749
Study First Received: February 13, 2006
Last Updated: May 20, 2008

Keywords provided by University Hospital Birmingham:
Chronic Kidney Disease
Arterial Stiffness

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents processed this record on August 23, 2017