Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry) (PEP-ASV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04133350
Recruitment Status : Recruiting
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Collaborators:
Inova Fairfax Hospital
Heart and Diabetes Center North Rhine-Westphalia
CLEMENS HOSPITAL
Resmed Inc
Information provided by (Responsible Party):
David Whellan, Thomas Jefferson University

Brief Summary:
This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.

Condition or disease Intervention/treatment Phase
Sleep Disorder; Breathing-Related Heart Failure Behavioral: Active Patient Engagement Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy Pilot Registry (PEP ASV Pilot Registry)
Estimated Study Start Date : October 16, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Behavioral: Active Patient Engagement
    The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.


Primary Outcome Measures :
  1. Adherence (hours/night) [ Time Frame: 3 months ]
    Demonstrate acceptable adherence to ASV therapy can be achieved in patients with moderate to severe SDB in a recently hospitalized population of Heart Failure patients with preserved ejection fraction (HFpEF).


Secondary Outcome Measures :
  1. Quality of Life Score [ Time Frame: 3 months ]
    The study will determine if acceptable adherence to this therapy can be achieved in this population using the AirCurve 10 device.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Patients 18 years or older 2. Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%) 3. Hospital admission or equivalent (such as ER visit alone or clinic visit alone) and acute decompensated HF as determined by:

    1. Dyspnea at rest or with minimal exertion AND
    2. Treatment with at least one dose of IV diuretic or ultrafiltration AND
    3. At least two of the following signs and symptoms:

    i. Orthopnea ii. Pulmonary rales that do not clear with cough iii. Congestion on chest X-ray iv. Local BNP or NT pro-BNP level:

  • No current AFib: BNP≥100 pg/mL or NT pro-BNP≥300 pg/mL OR
  • Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL 4. Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr) 5. Patient is able to fully understand study information and sign informed consent

Exclusion Criteria:

  1. Right-sided heart failure without left-sided failure
  2. Current chronic use (within 4 weeks of registry entry) of any PAP therapy (e.g., CPAP, APAP, or bi-level) or contraindicated for PAP therapy
  3. Sustained systolic blood pressure <80 mmHg at baseline
  4. Complex congenital heart disease
  5. Constrictive pericarditis
  6. Chronic hypoxemia as evidenced by sustained oxygen saturation ≤ 85% at rest during the day or at start of nocturnal oximetry recording or regular use of oxygen therapy (day or night)
  7. Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry
  8. Definite clinically evident acute myocardial infarction within 3 months of registry entry
  9. Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
  10. Moderate or greater valvular heart disease as the primary reason for heart failure
  11. In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate
  12. Inability to comply with planned study procedures

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): NCT04133350


Contacts
Layout table for location contacts
Contact: Claire Chenault, MS 2159557835 mcc035@jefferson.edu

Locations
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Claire Chenault    215-955-7835    mcc035@jefferson.edu   
Principal Investigator: David Whellan, MD         
United States, Virginia
INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital) Recruiting
Falls Church, Virginia, United States, 22042
Contact: Stephanie Garofalo    703-776-2018    stephanie.garofalo@inova.org   
Principal Investigator: Mitchell Psotka, MD         
Germany
Herz- und Diabeteszentrum, Nordrhein-Westfalen Recruiting
Bad Oeynhausen, Ruhr-Universität Bochum, Germany
Contact: Henrik Fox       hfox@hdz.nrw.de   
Ludgerus Clinic, Department of Cardiology, Clemens Hospital Recruiting
Münster, Germany
Contact: Olaf Oldenburg    49 251-976-2481    o.oldenburg@alexianer.de   
Sponsors and Collaborators
Thomas Jefferson University
Inova Fairfax Hospital
Heart and Diabetes Center North Rhine-Westphalia
CLEMENS HOSPITAL
Resmed Inc

Layout table for additonal information
Responsible Party: David Whellan, MD, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT04133350     History of Changes
Other Study ID Numbers: 19P.115
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Wake Disorders
Heart Failure
Heart Diseases
Cardiovascular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders