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Left Ventricular Hypertrophy and Spironolactone in End Stage Renal Disease

Cardiac Magnetic Resonance Imaging in Hemodialysis Patients

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00548912
Enrollment
0
Registered
2007-10-24
Start date
2007-10-31
Completion date
2008-10-31
Last updated
2021-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

Keywords

Kidney Failure, Chronic, Hemodialysis, Spironolactone

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.

Interventions

DRUGSpironolactone

Sponsors

Dawnmarie DeFazio
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* hemodialysis patients

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Left ventricular mass9 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026