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The Role of Sleep Disordered Breathing in Heart Failure Admissions

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ClinicalTrials.gov Identifier: NCT02505867
Recruitment Status : Terminated (lack of funding)
First Posted : July 22, 2015
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Rami Khayat, The Ohio State University

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).

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndromes Heart Failure Device: Adaptive Servo Ventilation Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Sleep Disordered Breathing in Heart Failure Admissions
Study Start Date : November 2014
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Device - ASV Therapy
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
Device: Adaptive Servo Ventilation
Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
Other Name: Bipap AutoSV
No Intervention: Control
No device provided



Primary Outcome Measures :
  1. Hospital Readmissions [ Time Frame: Six Months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: Six Months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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:

    1. AHI>15 with more than 50% apneas being central (CSA); or
    2. AHI>30 events with more than 50% of the events being obstructive (severe OSA) in patients with LVEF <30%.
  3. 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
  4. LVEF <45% within 1 year of admission. An echocardiogram may be performed to confirm the LVEF during the hospitalization to determine eligibility.
  5. 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:

  1. 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.
  2. 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.
  3. Cardiogenic shock and hemodynamic instability with MAP less than 55 mmHg off vasopressors, or concurrently on vasopressor treatment, left ventricular assist devices, or intra-aortic Balloon Pump. Inotropic agents will not constitute an exclusion criterion. Patients will be eligible once more stable off vasopressors.
  4. 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%.
  5. 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
  6. Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal.
  7. Moderate to severe chronic obstructive lung disease (FEV1/FVC < 55%).
  8. 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.
  9. Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness or heart failure
  10. Patients who report severe sleepiness or who consider themselves at risk while driving.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505867


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Rami Khayat
Philips Respironics
Investigators
Principal Investigator: Rami Khayat, MD Ohio State University
Principal Investigator: William Abraham, MD Ohio State University

Responsible Party: Rami Khayat, Principal Investigator, The Ohio State University
ClinicalTrials.gov Identifier: NCT02505867     History of Changes
Other Study ID Numbers: 2013H0228
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea Syndromes
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathologic Processes