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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Rami Khayat, Ohio State University
ClinicalTrials.gov Identifier:
NCT00679549
First received: May 15, 2008
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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 Intervention
Heart Failure
Obstructive Sleep Apnea
Heart Failure, Congestive
Device: CPAP Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • EF Improvement [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • BNP, BUN, Creatine levels [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 170
Study Start Date: March 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DEVICE
Provided CPAP as an inpatient
Device: CPAP Therapy
CPAP therapy is provided as an inpatient.
Other Name: CPAP Device
No Intervention: Control
No device provided

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].

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00679549

Locations
United States, Ohio
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
  More Information

No publications provided

Responsible Party: Rami Khayat, Associate Professor-Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT00679549     History of Changes
Other Study ID Numbers: 2008H0011
Study First Received: May 15, 2008
Last Updated: December 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
Heart Failure
Obstructive Sleep Apnea
OSA
CHF
Sleep apnea
CHD

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014