Spironolactone Safety in Dialysis Patients
This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Sri Narsipur, State University of New York - Upstate Medical University
First received: May 19, 2006
Last updated: June 3, 2013
Last verified: June 2013
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.
End Stage Renal Disease
Congestive Heart Failure
||Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
||Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
Primary Outcome Measures:
- safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Active Comparator: Spirnolactone
spironolactone administered to ESRD patients at low dose
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00328809
|SUNY Upstate Medical University
|Syracuse, New York, United States, 13210 |
State University of New York - Upstate Medical University
||Sriram S Narsipur, MD
||State University of New York - Upstate Medical University
No publications provided
||Sri Narsipur, Associate Professor of Medicine and Pediatrics, State University of New York - Upstate Medical University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 19, 2006
||June 3, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Mineralocorticoid Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing