Clinical trial NCT02963597: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated HF Patients With Sleep Apnea.
Official title: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Hypertension, Pulmonary
Heart Failure
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: Resmed Inc
First posted: 2016-11-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CPAP Device
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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%

Primary outcomes:
measure: Pulmonary Artery Systolic Pressure.
timeFrame: 48 hours
Secondary outcomes:
measure: Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs
timeFrame: 48 hours
measure: N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs
timeFrame: 48 hours
measure: Length of Stay
timeFrame: 1 year
measure: Blood Oxygenation.
timeFrame: 48 hours
measure: Heart Failure Symptoms
timeFrame: 48 hours
measure: Fluid Retention
timeFrame: 48 hours
measure: E/e' as an Assumption of LVEDP.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
state: North Rhine-Westphalia
Study officials:
affiliation: Albert Einstein Healthcare Network
name: Sunil Sharma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.