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

NCT02963597 | Completed Results DMC

• 1 other identifier: 4889
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

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.

Conditions

Sleep Apnea, Obstructive; Hypertension, Pulmonary; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Functional Parameters (6 Minute Walk Test) From Baseline to 48hrs

  48 hours

• N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) From Baseline to 48hrs

  48 hours

• Length of Stay

  1 year

• Blood Oxygenation.

  48 hours

• Heart Failure Symptoms

  48 hours

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

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

Group B

PLACEBO COMPARATOR

Standard medical therapy only.

Other: Standard Medical Therapy

Interventions

AirSense™ 10 AutoSet 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.

Group A

Standard Medical Therapy OTHER

Standard medical therapy according to current guidelines.

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• % 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%

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• Resmed Inc: collaborator

Study Sites (2)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Heart and Diabetes Center NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

• 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.

  PMID: 31004141 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension, Pulmonary; Heart Failure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Heart Diseases

Limitations and Caveats

PI has left the institution; efforts to contact unsuccessful; additional data information not available

Results Point of Contact

• Title: Dr Sunil Sharma
• Organization: Albert Einstein Healthcare Network

sharmasu@einstein.edu

2154566950

Study Officials

• Sunil Sharma, MD

  Albert Einstein Healthcare Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: CPAP Device

Study Record Dates

• First Submitted: November 10, 2016
• First Posted: November 15, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 15, 2018
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (1)