NCT00328809

Spironolactone Safety in Dialysis Patients

Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.

Conditions

• End Stage Renal Disease
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	spironolactone	spironolactone administered to ESRD patients at low dose

Timeline

• Start date: 2013-06-30
• Primary completion: 2017-06-30
• Completion: 2019-09-24
• First posted: 2006-05-22
• Last updated: 2020-10-22

Locations

1 site across 1 country: United States