Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286182
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2006-02-01
Brief Title:
Anemia in Heart Failure With a Preserved Ejection Fraction HFPEF
Sponsor:
Mathew S Maurer
Organization:
Columbia University
Study Overview
Official Title:
Efficacy of Treating Anemia in Heart Failure With a Preserved Ejection Fraction HFPEF on Ventricular Function Exercise Capacity and Health Status
Status:
COMPLETED
Status Verified Date:
2017-01
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 determine if treating anemia with subcutaneous erythropoetin in patients with heart failure and a preserved ejection fraction HFPEF will be associated with reverse ventricular remodeling significant improvements in exercise capacity and improved health status as compared with placebo
Detailed Description:
Heart failure frequently occurs in patients with a preserved ejection fraction HFPEF and affected subjects are predominantly elderly women with several co-morbid conditions Despite the diversity of underlying clinical pathologies and co-morbid conditions present in these patients a common pathophysiologic explanation is generally applied to explain their clinical symptoms Our preliminary data show that a significant subgroup with HFPEF has increases in ventricular volumes and expanded plasma volumes consistent with a volume overloaded state In the setting of a preserved EF with end diastolic volume increased stroke volume must increase indicating a high output state Anemia may be an important modifiable contributor to the observed high output and volume overload as well as exercise intolerance in elderly HFPEF patients abnormal ventricular remodeling and impaired overall health status and quality of life This protocol evaluates the impact of treating anemia in subjects with HFPEF The specific aims of the current study are to provide a comprehensive and mechanistically based assessment of how correcting anemia in subjects with HFPEF can impact on functional capacity ventricular structure and function and overall health status We propose to perform a randomized prospective double blind study in 80 subjects with HFPEF to test the hypothesis that the administration of subcutaneous erythropoietin will be associated with reverse ventricular remodeling significant improvements in exercise capacity and improved health status
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG027518-01 | NIH | None | httpsreporternihgovquickSearchR01AG027518-01 |