Spironolactone Safety in Dialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00328809
• Other study ID #: 1045057
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 30, 2013
• Est. completion date: September 24, 2019

Study information

• Verified date: October 2020
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 24, 2019
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure
• End Stage Renal Disease
• Heart Failure
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• spironolactone
spironolactone administered to ESRD patients at low dose

Locations

Country	Name	City	State
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	risk of hyperkalemia		6 months