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

NCT ID: NCT02963597

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2018-08-15

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.

Conditions

Sleep Apnea, Obstructive; Hypertension, Pulmonary; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

AirSense™ 10 AutoSet

Intervention Type: 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.

Standard Medical Therapy

Intervention Type: OTHER

Standard medical therapy according to current guidelines.

Group B

Standard medical therapy only.

Group Type: PLACEBO_COMPARATOR

Standard Medical Therapy

Intervention Type: OTHER

Standard medical therapy according to current guidelines.

Interventions

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.

Intervention Type: DEVICE

Standard Medical Therapy

Standard medical therapy according to current guidelines.

Intervention Type: OTHER

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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Resmed Inc

UNKNOWN

Sponsor Role: collaborator

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Healthcare Network

Locations

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Countries

United States; Germany

References

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.

Reference Type: DERIVED

PMID: 31004141 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

4889

Identifier Type: -

Identifier Source: org_study_id