Status:
WITHDRAWN
Spironolactone Safety in Dialysis Patients
Lead Sponsor:
State University of New York - Upstate Medical University
Conditions:
End Stage Renal Disease
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00328809
Start Date
June 30 2013
End Date
September 24 2019
Last Update
October 22 2020
Active Locations (1)
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1
SUNY Upstate Medical University
Syracuse, New York, United States, 13210