Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

October 23, 2007

Last Updated Date

October 23, 2007

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Left ventricular mass [ Time Frame: 9 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Official Title ^ICMJE

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Single Group Assignment

Condition ^ICMJE

Kidney Failure, Chronic

Intervention ^ICMJE

Drug: Spironolactone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

hemodialysis patients

Exclusion Criteria:

non compliance
hyperkalemia
pregnancy
expected survival less than 9 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00548912

Responsible Party

Study ID Numbers ^ICMJE

RC-3267

Study Sponsor ^ICMJE

West Penn Allegheny Health System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Richard Marcus

West Penn Allegheny Health System

Information Provided By

West Penn Allegheny Health System

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP