Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Phase 4

Withdrawn

• Conditions: Kidney Failure, Chronic
• Interventions: Drug: Spironolactone

• Registration Number: NCT00548912
• Lead Sponsor: Dawnmarie DeFazio

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-23
• Study First Submitted QC: 2007-10-23
• Study First Posted: 2007-10-24
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• hemodialysis patients

Exclusion Criteria

• non compliance
• hyperkalemia
• pregnancy
• expected survival less than 9 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1 group - no arms	Spironolactone	no arm just error message

Primary Outcome Measures

Name	Time	Method
Left ventricular mass	9 months

Trial Locations

Locations (1)

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States