Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

This study has been completed.

First Received on October 23, 2007. No Changes Posted

Sponsor:	West Penn Allegheny Health System
Information provided by:	West Penn Allegheny Health System
ClinicalTrials.gov Identifier:	NCT00548912

Purpose

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

Condition	Intervention	Phase
Kidney Failure, Chronic	Drug: Spironolactone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Kidney Failure

Drug Information available for: Spironolactone

U.S. FDA Resources

Further study details as provided by West Penn Allegheny Health System:

Primary Outcome Measures:

Left ventricular mass [ Time Frame: 9 months ]

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

hemodialysis patients

Exclusion Criteria:

non compliance
hyperkalemia
pregnancy
expected survival less than 9 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548912

Locations

United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators

West Penn Allegheny Health System

Investigators

Principal Investigator:

Richard Marcus

West Penn Allegheny Health System

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00548912 History of Changes
Other Study ID Numbers:	RC-3267
Study First Received:	October 23, 2007
Last Updated:	October 23, 2007
Health Authority:	United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:

Kidney Failure, Chronic
Hemodialysis
Spironolactone

Additional relevant MeSH terms:

Kidney Failure, Chronic
Renal Insufficiency
Hypertrophy, Left Ventricular
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Cardiomegaly
Heart Diseases
Cardiovascular Diseases
Hypertrophy
Pathological Conditions, Anatomical

Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012