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

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ClinicalTrials.gov Identifier: NCT02963597
Recruitment Status : Unknown
Verified November 2016 by Sunil Sharma, Albert Einstein Healthcare Network.
Recruitment status was:  Recruiting
First Posted : November 15, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborator:
Ruhr University of Bochum
Information provided by (Responsible Party):
Sunil Sharma, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Hypertension, Pulmonary Heart Failure Device: AirSense™ 10 AutoSet Other: Standard Medical Therapy Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Auto-PAP for Pulmonary Hypertension Treatment in Decompensated Heart Failure Patients With Obstructive Sleep Apnea: A Two Center Pilot Study
Study Start Date : October 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Reduction in Pulmonary Artery systolic pressure. Reduction in PA systolic pressure. [ Time Frame: 48 hours ]
    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.


Secondary Outcome Measures :
  1. To compare changes in functional parameters (6 Minute Walk Test) from baseline to 48hrs [ Time Frame: 48 hours ]
  2. To compare changes in N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) from baseline to 48hrs [ Time Frame: 48 hours ]
  3. To compare changes in blood oxygenation from baseline to 48hrs [ Time Frame: 48 hours ]
  4. To compare changes in heart failure symptoms from baseline to 48hrs [ Time Frame: 48 hours ]
  5. To compare changes in fluid retention from baseline to 48hrs [ Time Frame: 48 hours ]
  6. To compare changes in echocardiographic parameters, including E/e' as assumption of Left Ventricular End Diastolic Pressure from baseline to 48hrs. [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02963597


Contacts
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Contact: Sunil Sharma, MD 2154566950 sharmasu@einstein.edu
Contact: Umer Mukhtar, MD 2154566950 mukhtaru@einstein.edu

Locations
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United States, Pennsylvania
Albert Einstein Healthcare Network Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Sunil Sharma, MD    215-456-6950    sharmasu@einstein.edu   
Contact: Umer Mukhtar, MD    215-456-6950    mukhtaru@einstein.edu   
Germany
Heart and Diabetes Center NRW Not yet recruiting
Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545
Contact: Olaf Oldenburg, MD       OOldenburg@hdz-nrw.ke   
Sponsors and Collaborators
Albert Einstein Healthcare Network
Ruhr University of Bochum
Investigators
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Principal Investigator: Sunil Sharma, MD Albert Einstein Healthcare Network

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sunil Sharma, Chair Department of Pulmonary and Critical Care, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT02963597     History of Changes
Other Study ID Numbers: 4889
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Hypertension, Pulmonary
Sleep Apnea, Obstructive
Hypertension
Heart Failure
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Lung Diseases