The Role of Sleep Disordered Breathing in Heart Failure Admissions

Rami Khayat1 site in 1 country12 target enrollmentNovember 2014

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

December 1, 2016

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rami Khayat

Responsible Party

Sponsor Investigator

Principal Investigator

Rami Khayat

Principal Investigator

Ohio State University

Eligibility Criteria

Inclusion Criteria

•Admission diagnosis of heart failure and AHFS as defined by the following: A chief complaint of dyspnea or fatigue; elevated left ventricular pressure. Elevated left ventricular pressure is indicated by at least one of the following: signs of volume overload pedal edema, crackles, consistent chest X-ray, increased measurement of left ventricular end-diastolic diameter or volume, or elevated BNP level.
•Previously unrecognized or recognized but untreated SDB diagnosed or confirmed on attended inpatient sleep study during the index hospitalization with AHFS. SDB is defined as one of the following syndromes:
•AHI\>15 with more than 50% apneas being central (CSA); or
•AHI\>30 events with more than 50% of the events being obstructive (severe OSA) in patients with LVEF \<30%.
•Projected length of stay \>2 days on admission day to ensure uniformity of the underlying severity of the AHFS and to enable the introduction of the ASV device and education
•LVEF \<45% within 1 year of admission. An echocardiogram may be performed to confirm the LVEF during the hospitalization to determine eligibility.
•Ongoing targeted treatment for heart failure during the current hospitalization including at least one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy.
•Exclusion criteria:
•Patients who were on supplemental oxygen for an indication other than SDB or heart failure prior to admission. These are patients who have chronic respiratory insufficiency.
•Patients on treatment targeting CSA or OSA (ASV, oxygen, or CPAP); and patients who already provided and rejected positive airway pressure therapy due to intolerance of the pressure or the claustrophobia.