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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.
Sponsor:
Collaborator:
British Heart Foundation
Information provided by:
University Hospital Birmingham
ClinicalTrials.gov Identifier:
NCT00291720
First received: February 13, 2006
Last updated: May 20, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in aortic distensibility and large vessel augmentation [ Time Frame: 9 months ] [ Designated as safety issue: No ]

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.
Other Name: Spironolactone
Placebo Comparator: Placebo
matching placebo medication for the control group
 Drug: Placebo
matching placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291720

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Research & Development Office, University Hospital Birmingham
ClinicalTrials.gov Identifier: NCT00291720     History of Changes
Other Study ID Numbers: RPK2749, 04/Q2707/294
Study First Received: February 13, 2006
Last Updated: May 20, 2008
Health Authority: United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Spironolactone
Aldosterone Antagonists
 Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013