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

NCT ID: NCT04133350

Last Updated: 2021-05-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-16
• Study Completion Date: 2021-02-01

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.

Conditions

Sleep Disorder; Breathing-Related; Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Active Patient Engagement

All patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention.

Group Type: EXPERIMENTAL

Active Patient Engagement

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

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

Sponsors

Inova Fairfax Hospital

OTHER

Sponsor Role: collaborator

Heart and Diabetes Center North Rhine-Westphalia

OTHER

Sponsor Role: collaborator

CLEMENS HOSPITAL

UNKNOWN

Sponsor Role: collaborator

Resmed Inc

UNKNOWN

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)

Falls Church, Virginia, United States

Herz- und Diabeteszentrum, Nordrhein-Westfalen

Bad Oeynhausen, Ruhr-Universität Bochum, Germany

Ludgerus Clinic, Department of Cardiology, Clemens Hospital

Münster, , Germany

Countries

United States; Germany

Other Identifiers

19P.115

Identifier Type: -

Identifier Source: org_study_id