Spironolactone Safety in Dialysis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00328809|
Recruitment Status : Withdrawn (personnel shortage)
First Posted : May 22, 2006
Last Update Posted : October 22, 2020
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|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease Congestive Heart Failure||Drug: spironolactone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone|
|Estimated Study Start Date :||June 30, 2013|
|Estimated Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||September 24, 2019|
spironolactone administered to ESRD patients at low dose
- risk of hyperkalemia [ Time Frame: 6 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00328809
|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:||Sri Narsipur, Associate Professor of Medicine and Pediatrics, State University of New York - Upstate Medical University|
|Other Study ID Numbers:||
|First Posted:||May 22, 2006 Key Record Dates|
|Last Update Posted:||October 22, 2020|
|Last Verified:||October 2020|
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Mineralocorticoid Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing