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

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.

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Key information

Conditions

End-stage Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shibukawa Clinic

Shizuoka, 424-0053, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone

Drug

Primary outcomes

cardio- and cerebrovascular events

Secondary outcomes

death from all causes

Sponsors and collaborators

Lead sponsor

Dialysis Outcomes Heart Failure Aldactone Study Group

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2008
First posted: Sep 19, 2012
Registry last updated: Sep 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed