Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-22 @ 3:12 AM
Study NCT ID:
NCT02505867
Status:
TERMINATED
Last Update Posted:
2019-06-11
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Role of Sleep Disordered Breathing in Heart Failure Admissions
Sponsor:
Rami Khayat
Organization:
Study Overview
Official Title:
The Role of Sleep Disordered Breathing in Heart Failure Admissions
Status:
TERMINATED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
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 evaluate the effect of in-hospital diagnosis and treatment of sleep disordered breathing (SDB) on post-discharge mortality and readmissions in- hospitalized patients with acute heart failure syndrome and reduced ejection fraction (HFrEF).
Detailed Description:
The purpose of this study is to evaluate the effect of in-hospital diagnosis and treatment of sleep disordered breathing (SDB) on post-discharge mortality and readmissions in- hospitalized patients with heart failure and reduced ejection fraction (HFrEF). The study is a randomized controlled trial in HFrEF patients who are hospitalized with acute heart failure syndrome (AHFS) and have an in-hospital sleep study diagnostic of SDB. Participants will be randomized to either the current standard of care of AHFS treatment or an intervention arm in which expedited treatment with adaptive servo ventilation is initiated immediately upon in-hospital diagnosis of SDB.
Study Oversight
Has Oversight DMC:
True
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?: