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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sleep Apnea, Obstructive; Hypertension, Pulmonary
• Intervention / Treatment: Device: AirSense™ 10 AutoSet; Other: Standard Medical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • North Rhine-Westphalia
    • Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
      • Heart and Diabetes Center NRW
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Albert Einstein Healthcare Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Collaborators: Resmed Inc
• Investigators: Principal Investigator: Sunil Sharma, MD, Albert Einstein Healthcare Network

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 15, 2018

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 13, 2020
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Heart Failure; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension; Apnea; Hypertension, Pulmonary
• Other Study ID Numbers: 4889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO