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NCT00548912 Clinical Trial

Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Kidney Failure, Chronic Clinical Trial

Official title:
Cardiac Magnetic Resonance Imaging in Hemodialysis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00548912
Other study ID # RC-3267
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date October 2007
Est. completion date October 2008

Study information
Verified date November 2021
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The hypothesis of this trial is to assess the effect of spironolactone on heart size and mass

Description:

Dialysis patients have significant morbidity and mortality associated with left ventricular hypertrophy and cardiac failure. Aldosterone may have an important role in the development of myocardial hypertrophy and remodeling. Animal studies have demonstrated beneficial effects of aldosterone antagonists on myocardial hypertrophy, and human studies have shown significant survival benefit in a non-dialysis population with congestive heart failure. This study evaluates the effect of spironolactone (an aldosterone receptor antagonist) on cardiac hypertrophy in the end-stage renal disease population.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - hemodialysis patients Exclusion Criteria: - non compliance - hyperkalemia - pregnancy - expected survival less than 9 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Spironolactone

Locations
Country Name City State
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Dawnmarie DeFazio

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Left ventricular mass 9 months
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