Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

• Sponsor: Dawnmarie DeFazio (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00548912
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic	Drug: Spironolactone	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cardiac Magnetic Resonance Imaging in Hemodialysis Patients
• Actual Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 group - no arms no arm just error message	Drug: Spironolactone

Outcome Measures

Primary Outcome Measures

1. Left ventricular mass [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• hemodialysis patients

Exclusion Criteria:

• non compliance

• hyperkalemia

• pregnancy

• expected survival less than 9 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• Dawnmarie DeFazio

Investigators

• Principal Investigator: Richard Marcus, West Penn Allegheny Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dawnmarie DeFazio, Nephrolgist, Co-Investigator, West Penn Allegheny Health System
• ClinicalTrials.gov Identifier: NCT00548912
• Other Study ID Numbers: RC-3267
• First Posted: Oct 24, 2007
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Dawnmarie DeFazio, Nephrolgist, Co-Investigator, West Penn Allegheny Health System: Kidney Failure, Chronic; Hemodialysis; Spironolactone
• Additional relevant MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Spironolactone

Study Results

No Results Posted as of Dec 9, 2021