Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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].
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEVICE | Experimental | Provided CPAP as an inpatient |
|
| Control | No Intervention | No device provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP Therapy | Device | CPAP therapy is provided as an inpatient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rami N Khayat, MD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43212 | United States |
Not provided
150 patients provided the baseline measurements and were randomized and included in the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | DEVICE | Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient. |
| FG001 | Control | No device provided |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DEVICE | Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient. |
| BG001 | Control | No device provided |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 %. | Posted | Mean | Standard Deviation | percent ejection fraction | at baseline and 3 days post randomization |
|
3 months post randomization
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DEVICE | Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rami Khayat | The Ohio State Unveristy | 6142477717 | rami.khayat@osumc.edu |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| EG001 | Control | No device provided | 0 | 75 | 0 | 75 |
Not provided
Not provided
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |