Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123955
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2005-07-22
Brief Title:
PIE II Pharmacological Intervention in the Elderly II
Sponsor:
Wake Forest University
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Exercise Intolerance in Elderly Diastolic Heart Failure
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine whether spironolactone will improve exercise tolerance and quality of life in elderly patients with heart failure preserved ejection fraction HFPEF
Detailed Description:
Exercise intolerance due to HFPEF is a major cause of disability among older Americans Several lines of evidence suggest that aldosterone antagonism may improve exercise tolerance in HFPEF Therefore the primary aim of this study is to test the hypothesis that spironolactone will improve exercise tolerance and quality of life in elderly patients with isolated HFPEF A total of 72 participants aged 60 or older will be randomized to receive either spironolactone 25mg daily or a placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01AG018915-05 | NIH | None | httpsreporternihgovquickSearch2R01AG018915-05 |
| R01AG018915 | NIH | None | None |