Spironolactone Safety in Dialysis Patients
NCT00328809 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2020-10-22
Summary
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.
Conditions
- End Stage Renal Disease
- Congestive Heart Failure
Interventions
- DRUG
-
spironolactone
spironolactone administered to ESRD patients at low dose
Sponsors & Collaborators
-
State University of New York - Upstate Medical University
lead OTHER
Principal Investigators
-
Sriram S Narsipur, MD · State University of New York - Upstate Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-06-30
- Primary Completion
- 2017-06-30
- Completion
- 2019-09-24
Countries
- United States
Study Locations
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