Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00328809
Status:
WITHDRAWN
Last Update Posted:
2020-10-22
First Post:
2006-05-19
Brief Title:
Spironolactone Safety in Dialysis Patients
Sponsor:
State University of New York - Upstate Medical University
Organization:
State University of New York - Upstate Medical University
Study Overview
Official Title:
Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis A Pilot Study to Assess Safety and Tolerability of Spironolactone
Status:
WITHDRAWN
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
personnel shortage
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None