Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Dawnmarie DeFazio

Status and phase: Withdrawn; Phase 4

Conditions: Kidney Failure, Chronic

Treatments: Drug: Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT00548912

RC-3267

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• hemodialysis patients

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

1 group - no arms

Other group

Description:

no arm just error message

Treatment:

Drug: Spironolactone