Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

Dialysis Outcomes Heart Failure Aldactone Study Group1 site in 1 country157 target enrollmentApril 2008

ConditionsEnd-stage Renal Failure

InterventionsSpironolactone

DrugsSpironolactone

Overview

Phase: Phase 4
Intervention: Spironolactone
Conditions: End-stage Renal Failure
Sponsor: Dialysis Outcomes Heart Failure Aldactone Study Group
Enrollment: 157
Locations: 1
Primary Endpoint: cardio- and cerebrovascular events
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

December 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Dialysis Outcomes Heart Failure Aldactone Study Group

Responsible Party

Principal Investigator

Yoshihiro Matsumoto

MD., PhD.

Dialysis Outcomes Heart Failure Aldactone Study Group

Eligibility Criteria

Inclusion Criteria

•Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
•With an average serum potassium level (immediately before dialysis on the first day of the week) of \<6.5 mEq/l over the previous 2 months
•With a 24-hour urine output of \<500 ml