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

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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure; Sleep Disorder; Breathing-Related
• Intervention / Treatment: Behavioral: Active Patient Engagement

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Münster, Germany
    • Ludgerus Clinic, Department of Cardiology, Clemens Hospital
  • Ruhr-Universität Bochum
    • Bad Oeynhausen, Ruhr-Universität Bochum, Germany
      • Herz- und Diabeteszentrum, Nordrhein-Westfalen
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)

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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Patient Engagement; All patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence (hours/night)	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).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Score -	Quality of life will be assessed using the KCCQ-12, a 12-item validated instrument that measures Quality of Life in heart failure patients on a scale of 0-100. Higher scores indicate higher Quality of Life	3 months

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Heart and Diabetes Center North Rhine-Westphalia; Inova Fairfax Hospital; Resmed Inc; CLEMENS HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2019
• Primary Completion (Actual): February 1, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (Actual): October 21, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Heart Failure; Sleep Wake Disorders
• Other Study ID Numbers: 19P.115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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