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Sponsored by: |
State University of New York - Upstate Medical University |
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Information provided by: | State University of New York - Upstate Medical University |
ClinicalTrials.gov Identifier: | NCT00328809 |
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.
Condition | Intervention | Phase |
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End Stage Renal Disease Congestive Heart Failure |
Drug: spironolactone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Crossover Assignment, Safety Study |
Official Title: | Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
SUNY Upstate Medical University | |
Syracuse, New York, United States, 13210 |
Principal Investigator: | Sriram S Narsipur, MD | State University of New York - Upstate Medical University |
Responsible Party: | SUNY Upstate Medical University ( Sriram S. Narsipur, MD ) |
Study ID Numbers: | 1045057 |
Study First Received: | May 19, 2006 |
Last Updated: | June 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00328809 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Heart Failure Renal Insufficiency Heart Diseases Hormone Antagonists Diuretics Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Cardiovascular Agents |
Hormones Spironolactone Urologic Diseases Aldosterone Antagonists Renal Insufficiency, Chronic Kidney Diseases Kidney Failure |
Heart Failure Renal Insufficiency Heart Diseases Hormone Antagonists Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Cardiovascular Agents Pharmacologic Actions |
Spironolactone Aldosterone Antagonists Urologic Diseases Renal Insufficiency, Chronic Natriuretic Agents Therapeutic Uses Cardiovascular Diseases Kidney Diseases Kidney Failure |