Trial | NCT01687699  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    157
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.
Study Started
Apr 30
2008
Primary Completion
Dec 31
2008
Last Update
Sep 19
2012
Estimate

Drug Spironolactone

spironolactone Experimental

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

Exclusion Criteria:

A history of noncompliance
Unstable vascular access
Hypotension
Hepatic failure
Active cancer
Any life-threatening disease other than ESRD
No Results Posted