Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.
Chronic heart failure (HF) is a highly prevalent disease, with a lifetime risk of approximately 20%. Sleep apnea is a common co-morbid condition, occurring in approximately half of patients with chronic HF, and often has predominantly central or mixed obstructive and central characteristics. Although it is associated with increased mortality in patients with HF, sleep apnea is usually asymptomatic and patients are therefore often unwilling to accept standard therapy with positive airway pressure. At the outset of this study, there were three treatment modalities currently recommended by the American Academy of Sleep Medicine for the treatment of predominantly central sleep apnea in HF patients: nocturnal supplemental oxygen (NSO), continuous positive airway pressure (CPAP) and adaptive servo-ventilation (ASV). Recently, ASV was found to increase mortality in patients with heart failure with reduced ejection fraction and central sleep apnea. There are only limited data on the comparative efficacy and tolerability of these three modalities. The present study is designed to compare these modalities with respect to effects on ventricular function, exercise capacity, and other measures of cardiovascular risk.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP | Experimental | Nocturnal continuous positive airway pressure |
|
| NSO | Experimental | Nocturnal supplemental oxygen |
|
| HLSE | Other | Healthy lifestyle and sleep education control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous positive airway pressure | Device | Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Ejection Fraction | Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Oxygen Consumption (VO2 Peak) | Treadmill exercise testing will be performed using a motor-driven treadmill and a modified Naughton protocol, with a lightweight disposable pneumotach device positioned in the participant's mouth interfaced with a metabolic cart. Change in VO2 peak between baseline and final visit will be the co-primary outcome of the study. Secondary outcome measures from cardiopulmonary exercise testing include VO2 at anaerobic threshold and VE/VCO2 slope. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniel J Gottlieb, MD MPH | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CPAP | Nocturnal continuous positive airway pressure Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| FG001 | Oxygen | Nocturnal supplemental oxygen Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| FG002 | HLSE | Healthy lifestyle and sleep education control Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CPAP | Nocturnal continuous positive airway pressure Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF. | All participants with both baseline and follow-up echocardiograms. There were 5 dropouts from the CPAP group, 2 from the NSO group and 1 from the HLSE group. | Posted | Mean | Standard Deviation | percent of LV diastolic volume | 3 months |
|
3 months
AE data collected at 1, 2, 4, and 8 weeks of follow-up and at final visit.
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 | CPAP | Nocturnal continuous positive airway pressure Continuous positive airway pressure: Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased dyspnea | Cardiac disorders | Systematic Assessment | Dyspnea new or worse shortness of breath since prior contact |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Gottlieb | VA Boston Healthcare System | 857-203-6175 | daniel.gottlieb@va.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2017 | Dec 26, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
Not provided
Not provided
Continuous positive airway pressure (CPAP) and supplemental oxygen
Not provided
Not provided
Not provided
| Nocturnal supplemental oxygen | Device | Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia |
|
|
| Healthy Lifestyle and Sleep Education | Behavioral | A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
|
|
| 3 months |
| 24-hour Ambulatory Blood Pressure | 24-hour blood pressure will be measured using a blood pressure cuff that is connected by rubber tubing to a small pressure monitoring device, programmed to measure BP at 20 minute intervals during the day and 30 minute intervals at night (11 PM to 7 AM) for a period of 24 hours. The investigators will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects. | 3 months |
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA |
| Boston |
| Massachusetts |
| 02130 |
| United States |
| BG001 |
| Oxygen |
Nocturnal supplemental oxygen Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| BG002 | HLSE | Healthy lifestyle and sleep education control Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Oxygen | Nocturnal supplemental oxygen Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
| OG002 | HLSE | Healthy lifestyle and sleep education control Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle |
|
|
| Secondary | Peak Oxygen Consumption (VO2 Peak) | Treadmill exercise testing will be performed using a motor-driven treadmill and a modified Naughton protocol, with a lightweight disposable pneumotach device positioned in the participant's mouth interfaced with a metabolic cart. Change in VO2 peak between baseline and final visit will be the co-primary outcome of the study. Secondary outcome measures from cardiopulmonary exercise testing include VO2 at anaerobic threshold and VE/VCO2 slope. | All randomized participants completing baseline and follow-up cardiopulmonary exercise testing | Posted | Mean | Standard Deviation | ml/kg/min | 3 months |
|
|
|
| Secondary | 24-hour Ambulatory Blood Pressure | 24-hour blood pressure will be measured using a blood pressure cuff that is connected by rubber tubing to a small pressure monitoring device, programmed to measure BP at 20 minute intervals during the day and 30 minute intervals at night (11 PM to 7 AM) for a period of 24 hours. The investigators will assess 24-hour mean arterial pressure as the primary blood pressure outcome, with additional assessment of nocturnal versus diurnal blood pressure effects. | Participants completing 24-hour ambulatory BP monitoring at final visit | Posted | Mean | Standard Deviation | torr | 3 months |
|
|
|
| 0 |
| 31 |
| 4 |
| 31 |
| 10 |
| 31 |
| EG001 | Oxygen | Nocturnal supplemental oxygen Nocturnal supplemental oxygen: Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle | 0 | 29 | 4 | 29 | 13 | 29 |
| EG002 | HLSE | Healthy lifestyle and sleep education control Healthy Lifestyle and Sleep Education: A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle | 0 | 14 | 2 | 14 | 4 | 14 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Heart failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Exacerbation of heart failure symptoms requiring hospitalization |
|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Fall with injury requiring hospitalization |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment | Atrial fibrillation requiring intervention |
|
| Chest pain | Cardiac disorders | Systematic Assessment | Hospitalized for chest pain |
|
|
| Chest discomfort | Cardiac disorders | Systematic Assessment | New or worse discomfort or pain in chest since prior contact |
|
| Excessive sleepiness | Nervous system disorders | Systematic Assessment | Sleepiness interfering with work or driving since prior contact |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Decreased renal function | Renal and urinary disorders | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Toothache | General disorders | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | Non-systematic Assessment |
|
| Fall with injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |