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

NCT00679549 | Completed Results DMC

• 1 other identifier: 2008H0011
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Obstructive Sleep Apnea; Heart Failure, Congestive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 %.

  at baseline and 3 days post randomization

Study Arms (2)

DEVICE

EXPERIMENTAL

Provided CPAP as an inpatient

Device: CPAP Therapy

Control

NO INTERVENTION

No device provided

Interventions

CPAP Therapy DEVICE

CPAP therapy is provided as an inpatient.

Also known as: CPAP Device

DEVICE

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients who are already diagnosed with OSA
• Patients with Central Sleep Apnea
• Patients with diastolic only heart failure
• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43212, United States

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

rami.khayat@osumc.edu

6142477717

Study Officials

• Rami N Khayat, 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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Clinical

Study Record Dates

• First Submitted: May 15, 2008
• First Posted: May 19, 2008
• Study Start: March 1, 2008
• Primary Completion: March 22, 2014
• Study Completion: March 22, 2014
• Last Updated: May 14, 2019
• Results First Posted: May 14, 2019

Record last verified: 2019-04

Locations

US (1)