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

End-stage Renal Failure Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687699
• Other study ID #: dohas01
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2012
• Last updated: September 14, 2012
• Start date: April 2008

Study information

• Verified date: September 2012
• Source: Dialysis Outcomes Heart Failure Aldactone Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. primary completion date: December 2008
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• End-stage Renal Failure
• Kidney Failure, Chronic

Intervention

Drug:
• Spironolactone

Locations

Country	Name	City	State
Japan	Shibukawa Clinic	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Dialysis Outcomes Heart Failure Aldactone Study Group

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardio- and cerebrovascular events
Secondary	death from all causes

External Links

•   Link