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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00679549
• Collaborator: (none)
• Enrollment: 154
• Location: 1
• Arms: 2
• Duration (Months): 72.7
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Obstructive Sleep Apnea; Heart Failure, Congestive	Device: CPAP Therapy	N/A

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].

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Mar 22, 2014
• Actual Study Completion Date: Mar 22, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DEVICE Provided CPAP as an inpatient	Device: CPAP Therapy; CPAP therapy is provided as an inpatient.; Other Names: CPAP Device
No Intervention: Control No device provided

Outcome Measures

Primary Outcome Measures

1. Left Ventricular Ejection Fraction (LVEF) [at baseline and 3 days post randomization]

   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 %.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43212

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Rami N Khayat, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rami Khayat, Associate Professor-Clinical, Ohio State University
• ClinicalTrials.gov Identifier: NCT00679549
• Other Study ID Numbers: 2008H0011
• First Posted: May 19, 2008
• Last Update Posted: May 14, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Rami Khayat, Associate Professor-Clinical, Ohio State University: Heart Failure; Obstructive Sleep Apnea; OSA; CHF; Sleep apnea; CHD
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Heart Failure

Study Results

Participant Flow

Recruitment Details	150 patients provided the baseline measurements and were randomized and included in the trial.

Arm/Group Title	DEVICE	Control
Arm/Group Description	Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.	No device provided
Period Title: Overall Study
STARTED	75	75
COMPLETED	69	66
NOT COMPLETED	6	9

Baseline Characteristics

Arm/Group Title	DEVICE	Control	Total
Arm/Group Description	Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.	No device provided	Total of all reporting groups
Overall Participants	75	75	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (11)	57 (13.5)	57 (12)
Sex: Female, Male (Count of Participants)
Female	22 29.3%	21 28%	43 28.7%
Male	53 70.7%	54 72%	107 71.3%
Race/Ethnicity, Customized (Count of Participants)
African American	18 24%	17 22.7%	35 23.3%
White	57 76%	58 77.3%	115 76.7%

Outcome Measures

1. Primary Outcome

Title	Left Ventricular Ejection Fraction (LVEF)
Description	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 %.
Time Frame	at baseline and 3 days post randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DEVICE	Control
Arm/Group Description	Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.	No device provided
Measure Participants	69	66
Baseline	25.3 (10.6)	27.0 (11.3)
Conclusion	27.3 (11.9)	28.8 (10.5)

Adverse Events

Time Frame	3 months post randomization
Arm/Group Title	DEVICE		Control
Arm/Group Description	Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.		No device provided
All Cause Mortality
	DEVICE		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	DEVICE		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	DEVICE		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.