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Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

NCT ID: NCT00548912

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Kidney Failure, Chronic

Keywords

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Kidney Failure, Chronic Hemodialysis Spironolactone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 group - no arms

no arm just error message

Group Type OTHER

Spironolactone

Intervention Type DRUG

Interventions

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Spironolactone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* hemodialysis patients

Exclusion Criteria

* non compliance
* hyperkalemia
* pregnancy
* expected survival less than 9 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dawnmarie DeFazio

OTHER

Sponsor Role lead

Responsible Party

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Dawnmarie DeFazio

Nephrolgist, Co-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Richard Marcus

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RC-3267

Identifier Type: -

Identifier Source: org_study_id