Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study

Conditions
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Sleep Apnea, Obstructive, Hypertension, Pulmonary, Heart Failure

Intervention / Treatment
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* Device: AirSense™ 10 AutoSet
* Other: Standard Medical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or more Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure) Prior clinical diagnosis of heart failure Moderate to Severe predominately obstructive sleep disordered breathing documented by polygraphy with Apnea Hypopnea Index (AHI) ≥20e/h and 5% of the time spent <90% O2 Sat (minimum 2hr recording time) Patient is able to fully understand study information and sign informed consent Exclusion Criteria: Chronic renal insufficiency (Hemodialysis or serum creatinine > 2) Hemodynamically significant valvular disease Severe arthritis or inability to complete 6 Minute Walk Test Left Ventricular Assist Device/ heart transplant or hemodynamically unstable Patient taking any Pulmonary vasodilators, including home oxygen. Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy 80% of the respiratory events being central/Cheyne-Stokes breathing Recent cardiac surgery (within 30 days of admission) Recent stroke (within 30 days of admission or with persistent neurological deficits) Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CPAP Device
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs. | Device: AirSense™ 10 AutoSet<br>* 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.<br>Other: Standard Medical Therapy<br>* Standard medical therapy according to current guidelines.<br>|
| Placebo Comparator: Group B<br>Standard medical therapy only. | Other: Standard Medical Therapy<br>* Standard medical therapy according to current guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |