- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02505867
The Role of Sleep Disordered Breathing in Heart Failure Admissions
May 17, 2019 updated by: Rami Khayat
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Columbus, Ohio, United States, 43212
- The Ohio State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Device - ASV Therapy
Participants are provided with Adaptive Servo Ventilation (ASV) device during inpatient hospitalization or shortly after discharge.
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Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
Other Names:
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NO_INTERVENTION: Control
No device provided
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital Readmissions
Time Frame: Six Months
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Number of participant hospital readmissions
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Six Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (ACTUAL)
December 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
July 21, 2015
First Posted (ESTIMATE)
July 22, 2015
Study Record Updates
Last Update Posted (ACTUAL)
June 11, 2019
Last Update Submitted That Met QC Criteria
May 17, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013H0228
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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