Spironolactone Safety in Dialysis Patients
Information source: State University of New York - Upstate Medical University
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Congestive Heart Failure
Intervention: spironolactone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: State University of New York - Upstate Medical University Official(s) and/or principal investigator(s):
Sriram S Narsipur, MD, Principal Investigator, Affiliation: State University of New York - Upstate Medical University
Overall contact:
Sriram S Narsipur, MD, Phone: 3154645290, Email: fagana@upstate.edu
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.
Clinical Details
Official title: Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
Study design: Randomized, Double-Blind, Placebo Control, Crossover Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- They must be at least 18 years of age.
- They must understand the study purpose and give their written informed consent.
- They must have been stable on chronic hemodialysis for at least three months before
enrollment into the study.
- Hemodialysis subjects will be included if they have had a left ventricular ejection
fraction measured within the past six months with a value no more than 45 percent. A
repeat, standardized echocardiogram will be used to confirm left ventricular ejection
fraction.
Exclusion Criteria:
- Subjects with primary operable valvular heart disease.
- Subjects with a congenital heart disease.
- Subjects with unstable angina.
- Subjects with primary hepatic failure.
- Subjects with active cancer or any life-threatening disease (other than heart failure
or end-stage renal disease).
- Subjects who have undergone heart transplantation or who are awaiting heart
transplantation are also ineligible.
- Subjects on a renal transplant list will be accepted into the study until the time of
successful renal transplantation and termination of dialysis.
- Subjects with habitually difficult to control hyperkalemia (serum potassium >6. 0
meq/L) in the previous month while on dialysis will be excluded.
- The inability to complete the 6-minute walk test will not be a reason to exclude
subjects from this study.
Locations and Contacts
Sriram S Narsipur, MD, Phone: 3154645290, Email: fagana@upstate.edu
SUNY Upstate Medical University, Syracuse, New York 13210, United States; Recruiting
Sriram S Narsipur, MD, Phone: 315-464-5290, Email: fagana@upstate.edu
Sriram S Narsipur, MD, Principal Investigator
Additional Information
Last updated: January 25, 2008
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