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| Name | Class |
|---|---|
| Resmed Inc | UNKNOWN |
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The objective of the study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters.
The ASAP-HF study is a prospective, randomized, controlled, two-center, study with a parallel group design, with subjects randomized to either control (no APAP) or active treatment (APAP) in a 1:1 ratio. Group A (active): standard medical therapy plus treatment with continuous APAP for 48hrs, or Group B (control): standard medical therapy only.
Many people who have heart failure (HF) also have sleep-disordered breathing (SDB), which is breathing irregularities during sleep. These irregularities may interrupt the sleep as well as increase the rate of progression of Heart Failure. The ASAP-HF study is being done to see if certain clinical outcomes are improved in acute decompensated heart failure (HF) patients with SDB by using a non-invasive breathing device continuously for a short period of time (48 hours) while patient is still in the hospital. The device is called AirSense™ 10 AutoSet (AutoSet). It consists of an air flow generator, air tubing, an air humidifier, and a mask. As the patient breathe through the mask, the AutoSet monitors breathing.
The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters . This device is not currently used to diagnose sleep apnea and its utility is not well studied. This study will establish the utility of the device in diagnosing sleep apnea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. |
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| Group B | Placebo Comparator | Standard medical therapy only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirSense™ 10 AutoSet | Device | The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Artery Systolic Pressure. | The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs | 6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters. | 48 hours |
| N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunil Sharma, MD | Albert Einstein Healthcare Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | United States | ||
| Heart and Diabetes Center NRW |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31004141 | Derived | Sharma S, Fox H, Aguilar F, Mukhtar U, Willes L, Bozorgnia B, Bitter T, Oldenburg O. Auto positive airway pressure therapy reduces pulmonary pressures in adults admitted for acute heart failure with pulmonary hypertension and obstructive sleep apnea. The ASAP-HF Pilot Trial. Sleep. 2019 Jul 8;42(7):zsz100. doi: 10.1093/sleep/zsz100. |
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Subjects were recruited from the inpatient clinical services of the Albert Einstein Medical Center Philadelphia (US) and from the Heart and Diabetes Center of North Rhine-Westphalia (Germany). Patients signed an informed consent for the study prior to any study-related procedure. Before randomization, all eligibility criteria were confirmed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines. |
| FG001 | Group B | Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provides non-invasive ventilatory support to treat patients with sleep-disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in the sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Pulmonary Artery Systolic Pressure. | The primary objective of this pilot study is to evaluate the effect of continuous positive airway pressure (PAP) therapy on pulmonary arterial (PA) pressures in acute decompensated heart failure (HF) patients with severe obstructive sleep apnea (OSA). The study will also assess changes in functional parameters, biomarkers, and echocardiographic parameters. | Patients pulmonary artery systolic pressures were measured by transthoracic echocardiography (TTE) on admission and 48 hours after enrollment. | Posted | Mean | 95% Confidence Interval | mmHg | 48 hours |
|
1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. AirSense™ 10 AutoSet: The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water. Standard Medical Therapy: Standard medical therapy according to current guidelines. |
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PI has left the institution; efforts to contact unsuccessful; additional data information not available
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Sunil Sharma | Albert Einstein Healthcare Network | 2154566950 | sharmasu@einstein.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2017 | Feb 2, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2017 | Mar 13, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006976 | Hypertension, Pulmonary |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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CPAP Device
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| Standard Medical Therapy | Other | Standard medical therapy according to current guidelines. |
|
To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after. |
| 48 hours |
| Length of Stay | The total stay in the hospital during the admission will be measured by days. | 1 year |
| Blood Oxygenation. | Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen. | 48 hours |
| Heart Failure Symptoms | Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes. Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | 48 hours |
| Fluid Retention | Change in fluid retention as measured by weight at baseline and after 48 hours. | 48 hours |
| E/e' as an Assumption of LVEDP. | Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs. | 48 hours |
| Bad Oeynhausen |
| North Rhine-Westphalia |
| 32545 |
| Germany |
| BG001 | Group B | Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Body mass index (BMI) | defined by weight (kg) / [height x height (m)] | Mean | Standard Deviation | kg/m2 |
|
| Type of heart failure according to EF (HFrEF/HFpEF) | Heart failure with preserved ejection fraction/HFpEF (ejection fraction more than 45%). Heart failure with reduced ejection fraction/HFrEF (ejection fraction less than 45%) | Count of Participants | Participants |
|
| Smoking history | Count of Participants | Participants |
|
| History of COPD | Count of Participants | Participants |
|
| Apnea-hypopnea index (AHI) | Apnea-hypopnea index (AHI) obtained by polygraphy (ApneaLink Air device). | Mean | Standard Deviation | events/hour |
|
| OG001 | Group B | Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines. |
|
|
| Secondary | Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs | 6-minute walk tests were performed on admission and repeated after 48 hours from the initial. The walked distance was measured in meters. | Posted | Mean | 95% Confidence Interval | meters | 48 hours |
|
|
|
| Secondary | N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs | To compare changes in N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) measured at baseline and compared to 48hrs after. | Posted | Mean | 95% Confidence Interval | picogram/mililiter | 48 hours |
|
|
|
| Secondary | Length of Stay | The total stay in the hospital during the admission will be measured by days. | Posted | Mean | 95% Confidence Interval | days | 1 year |
|
|
|
| Secondary | Blood Oxygenation. | Changes in arterial blood oxygenation will be compared via arterial blood gas analysis performed at baseline and after 48h to assess arterial pressure of oxygen. | Data was not available for all participants. | Posted | Mean | 95% Confidence Interval | mmHg | 48 hours |
|
|
|
| Secondary | Heart Failure Symptoms | Heart failure symptoms as assessed by the New York Heart Association scale (NYHA) classification at baseline and after 48 hours. NYHA scale ranges from Class I to IV. Higher classes are associated with worst outcomes. Class I: No symptoms and no limitation in ordinary physical activity. Class II: Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III: Marked limitation in activity due to symptoms, even during less-than-ordinary activity.Comfortable only at rest. Class IV: Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. | Data was not available for participants after 48 hours. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point | Posted | Mean | 95% Confidence Interval | units on a scale | 48 hours |
|
|
|
| Secondary | Fluid Retention | Change in fluid retention as measured by weight at baseline and after 48 hours. | Data after 48 hours was not available for the participants of the study. PI has left the institution; efforts to contact unsuccessful; data information not available for after 48hr time point | Posted | Mean | 95% Confidence Interval | Kg | 48 hours |
|
|
|
| Secondary | E/e' as an Assumption of LVEDP. | Measurement of E/e' in 2D echocardiography as an assumption of LVEDP and PV acceleration time comparing baseline and after 48hrs. | Data was not available for all the subjects at baseline and 48 hours after. PI has left the institution; efforts to contact unsuccessful; clarifying data information not available | Posted | Mean | 95% Confidence Interval | Ratio | 48 hours |
|
|
|
| Post-Hoc | Ejection Fraction in HFrEF | Calculated ejection fraction in patients with heart failure with reduced ejection fraction (<45%) at baseline and after 48 hours. | Analyzing only patients with heart failure with reduced ejection fraction (<45%). | Posted | Mean | 95% Confidence Interval | percentage (%) | 48 hours |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Group B | Standard medical therapy only. Standard Medical Therapy: Standard medical therapy according to current guidelines. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008171 | Lung Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| After 48 hours |
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| After 48 hours |
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| After 48 hours |
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| After 48 hours |
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| After 48 hours |
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