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

Albert Einstein Healthcare Network

Status: Completed

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

Treatments: Other: Standard Medical Therapy; Device: AirSense™ 10 AutoSet

Study type: Interventional

Funder types: Other

Identifiers

NCT02963597

4889

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 years or more
2. Decompensated Congestive Heart Failure with systolic Pulmonary Artery pressures of ≥50 mmHg (including Right Atrial pressure)
3. Prior clinical diagnosis of heart failure
4. 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)
5. Patient is able to fully understand study information and sign informed consent

Exclusion criteria

1. Chronic renal insufficiency (Hemodialysis or serum creatinine > 2)
2. Hemodynamically significant valvular disease
3. Severe arthritis or inability to complete 6 Minute Walk Test
4. Left Ventricular Assist Device/ heart transplant or hemodynamically unstable
5. Patient taking any Pulmonary vasodilators, including home oxygen.
6. Known diagnosis of Obstructive Sleep Apnea (OSA) and on active therapy
7. 80% of the respiratory events being central/Cheyne-Stokes breathing
8. Recent cardiac surgery (within 30 days of admission)
9. Recent stroke (within 30 days of admission or with persistent neurological deficits)
10. Severe Chronic Obstructive Pulmonary Disease defined as forced expiratory volume at one second (FEV1) < 50%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

Standard medical therapy plus AirSense™ 10 AutoSet for 48hrs.

Treatment:

Other: Standard Medical Therapy

Device: AirSense™ 10 AutoSet

Group B

Placebo Comparator group

Description:

Standard medical therapy only.

Treatment:

Other: Standard Medical Therapy