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

Information source: Dialysis Outcomes Heart Failure Aldactone Study Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-stage Renal Failure

Intervention: Spironolactone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Dialysis Outcomes Heart Failure Aldactone Study Group

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.

Clinical Details

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: cardio- and cerebrovascular events

Secondary outcome: death from all causes

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Shibukawa Clinic, Shizuoka 424-0053, Japan
Additional Information

Starting date: April 2008
Last updated: September 14, 2012

Page last updated: August 23, 2015

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