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The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Primary Purpose

Heart Failure, Obstructive Sleep Apnea, Heart Failure, Congestive

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CPAP Therapy

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Obstructive Sleep Apnea, OSA, CHF, Sleep apnea, CHD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Previously unrecognized OSA with an Apnea Hypopnea Index (AHI) > 15 events per hour on the attended in-hospital sleep study. Patients with apnea index of less than 5 events / hour are excluded (see design consideration for rationale)
Projected length of stay 3 days or more on the morning following the cardio-respiratory sleep study
Ongoing or planned targeted treatment for heart failure including one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy

Exclusion Criteria:

Patients who are already diagnosed with OSA
Patients with Central Sleep Apnea
Patients with diastolic only heart failure
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 off vasopressors.
Acute respiratory failure or insufficiency defined by P/F (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 50%
Overt neurological deficit
Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal
Patients scheduled for procedures that will interfere with post randomization measurement: This includes scheduled coronary bypass surgery, or expected left ventricular assist device placement.
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 CPAP device independently.
Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness

Sites / Locations

The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DEVICE

Control

Arm Description

Provided CPAP as an inpatient

No device provided

Outcomes

Primary Outcome Measures

Left Ventricular Ejection Fraction (LVEF)

Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) *100. the measurement unit of LVEF is %.

Secondary Outcome Measures

Full Information

NCT ID

NCT00679549

First Posted

May 15, 2008

Last Updated

April 23, 2019

Sponsor

Ohio State University

1. Study Identification

Unique Protocol Identification Number

NCT00679549

Brief Title

The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Official Title

The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

March 22, 2014 (Actual)

Study Completion Date

March 22, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate whether treating sleep apnea while in the hospital would help heart failure, and assist recovery from the worsening of the heart function more than the current clinical standard of waiting for treatment until the subject have left the hospital. Heart failure affects more than 2% of the US population and is the only cardiovascular disorder with rising incidence. The annual cost of CHF in 2005 was $ 27.9 billion, large percentage of which is the cost of hospitalizations for exacerbation of CHF. Half of patients with CHF have some form of sleep apnea, and most of them go undiagnosed. Patients with CHF and OSA benefit from treatment with CPAP as an outpatient. The society can benefit from developing recommendations for approaching sleep apnea in the hospitalized CHF patient, which may shorten length of stay, improve functional status of discharged patient, and reduce rehospitalizations.

Detailed Description

Target population: Patients admitted to the OSU Heart Hospital with ADHF routinely undergo a cardiorespiratory sleep study to identify OSA. Patients with ADHF who are newly diagnosed with OSA during the same hospital stay are eligible for this study. Enrollment: Given the presence of significant previously unrecognized OSA in 62% of patients hospitalized with ADHF, we expect to need to screen 270 patient volunteers to recruit 170 patients with OSA. Eligibility for randomization: The criteria for ADHF is admission diagnosis of heart failure; a chief complaint of dyspnea; and ejection fraction of 45% or less. Additionally, elevated left ventricular pressure as indicated by at least one sign and one symptom of volume overload (pedal edema, crackles, consistent chest X-ray, increased left ventricular end-diastolic diameter, or elevated BNP level) is required [46].

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Obstructive Sleep Apnea, Heart Failure, Congestive

Keywords

Heart Failure, Obstructive Sleep Apnea, OSA, CHF, Sleep apnea, CHD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DEVICE

Arm Type

Experimental

Arm Description

Provided CPAP as an inpatient

Arm Title

Control

Arm Type

No Intervention

Arm Description

No device provided

Intervention Type

Device

Intervention Name(s)

CPAP Therapy

Other Intervention Name(s)

CPAP Device

Intervention Description

CPAP therapy is provided as an inpatient.

Primary Outcome Measure Information:

Title

Left Ventricular Ejection Fraction (LVEF)

Description

Time Frame

at baseline and 3 days post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Previously unrecognized OSA with an Apnea Hypopnea Index (AHI) > 15 events per hour on the attended in-hospital sleep study. Patients with apnea index of less than 5 events / hour are excluded (see design consideration for rationale) Projected length of stay 3 days or more on the morning following the cardio-respiratory sleep study Ongoing or planned targeted treatment for heart failure including one of the following: IV diuretics, IV infusion of inotropes or vasodilators, or planned revascularization, or device therapy Exclusion Criteria: Patients who are already diagnosed with OSA Patients with Central Sleep Apnea Patients with diastolic only heart failure 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 off vasopressors. Acute respiratory failure or insufficiency defined by P/F (PaO2/FIO2) ratio less than 250, or FIO2 requirement more than 50% Overt neurological deficit Renal failure requiring renal replacement therapy; Patients will not be excluded if they were undergoing ultra-filtration for volume removal Patients scheduled for procedures that will interfere with post randomization measurement: This includes scheduled coronary bypass surgery, or expected left ventricular assist device placement. 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 CPAP device independently. Patients on long term or "bridging" inotropic infusion, or short life expectancy due to concomitant illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Rami N Khayat, MD

Organizational Affiliation

Ohio State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

12. IPD Sharing Statement

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The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

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