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Spironolactone Safety in Dialysis Patients

Primary Purpose

End Stage Renal Disease, Congestive Heart Failure

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
spironolactone
Sponsored by
State University of New York - Upstate Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SUNY Upstate Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spirnolactone

Arm Description

Outcomes

Primary Outcome Measures

risk of hyperkalemia

Secondary Outcome Measures

Full Information

First Posted
May 19, 2006
Last Updated
October 19, 2020
Sponsor
State University of New York - Upstate Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00328809
Brief Title
Spironolactone Safety in Dialysis Patients
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 Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
personnel shortage
Study Start Date
June 30, 2013 (Anticipated)
Primary Completion Date
June 30, 2017 (Anticipated)
Study Completion Date
September 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York - Upstate Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spirnolactone
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
spironolactone
Intervention Description
spironolactone administered to ESRD patients at low dose
Primary Outcome Measure Information:
Title
risk of hyperkalemia
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sriram S Narsipur, MD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33586138
Citation
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.
Results Reference
derived

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Spironolactone Safety in Dialysis Patients

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