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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Recruitment Status : Withdrawn (personnel shortage)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
Sponsor:
Information provided by (Responsible Party):
Sri Narsipur, State University of New York - Upstate Medical University

Tracking Information
First Submitted Date  ICMJE May 19, 2006
First Posted Date  ICMJE May 22, 2006
Last Update Posted Date October 22, 2020
Estimated Study Start Date  ICMJE June 30, 2013
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)		 risk of hyperkalemia [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spironolactone Safety in Dialysis Patients
Official Title  ICMJE Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
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 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • End Stage Renal Disease
  • Congestive Heart Failure
Intervention  ICMJE Drug: spironolactone
spironolactone administered to ESRD patients at low dose
Study Arms  ICMJE Experimental: Spirnolactone
Intervention: Drug: spironolactone
Publications * Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 3, 2013)		 0
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 24, 2019
Estimated Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00328809
Other Study ID Numbers  ICMJE 1045057
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sri Narsipur, State University of New York - Upstate Medical University
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE State University of New York - Upstate Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sriram S Narsipur, MD State University of New York - Upstate Medical University
PRS Account State University of New York - Upstate Medical University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP