The Role of Sleep Disordered Breathing in Heart Failure Admissions

NCT02505867 | Terminated Results DMC

• 1 other identifier: 2013H0228
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Apnea Syndromes; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Hospital Readmissions

  Number of participant hospital readmissions

  Six Months

Study Arms (2)

Device - ASV Therapy

EXPERIMENTAL

Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.

Device: Adaptive Servo Ventilation

Control

NO INTERVENTION

No device provided

Interventions

Adaptive Servo Ventilation DEVICE

Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.

Also known as: Bipap AutoSV

Device - ASV Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Acute respiratory failure or insufficiency defined by (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 40%. Patients are eligible to participate once their FIO2 requirement is below 30%.
• Overt neurological deficit or patients who arrived from a long-term care facility or expected to be discharged to one; and patients who have very poor functional outcome precluding ability to use the ASV device independently
• Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal.
• Moderate to severe chronic obstructive lung disease (FEV1/FVC \< 55%).
• Patients who are likely to receive heart transplant or left ventricular assist device (LVAD) in the subsequent year. These are patients who have high standing on the transplant list during the index hospitalization or have a cardiothoracic evaluation for implantation of LVAD.
• Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure
• Patients who report severe sleepiness or who consider themselves at risk while driving.
• Patients who fail the secondary screening procedure. Secondary screening procedure involves the patient being asked to wear the device and experience the pressure delivery for at least 30 minutes while relaxed.

Sponsors & Collaborators

• Rami Khayat: lead
• Philips Respironics: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Heart Failure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Rami Khayat
• Organization: The Ohio State Unveristy

rami.khayat@osumc.edu

6142477717

Study Officials

• Rami Khayat, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

• William Abraham, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: July 22, 2015
• Study Start: November 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)