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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687699

Enrollment

157

Registered

2012-09-19

Start date

2008-04-30

Completion date

Unknown

Last updated

2012-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Renal Failure

Keywords

cardiovascular event, hemodialysis, spironolactone

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.

Interventions

DRUGSpironolactone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
cardio- and cerebrovascular events	—

Secondary

Measure	Time frame
death from all causes	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026