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

Primary Purpose

Sleep Disorder; Breathing-Related, Heart Failure

Status

Terminated

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Active Patient Engagement

About this trial

This is an interventional supportive care trial for Sleep Disorder; Breathing-Related

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Right-sided heart failure without left-sided failure
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
Sustained systolic blood pressure <80 mmHg at baseline
Complex congenital heart disease
Constrictive pericarditis
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)
Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry
Definite clinically evident acute myocardial infarction within 3 months of registry entry
Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
Moderate or greater valvular heart disease as the primary reason for heart failure
In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate
Inability to comply with planned study procedures

Sites / Locations

Thomas Jefferson University
INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)
Herz- und Diabeteszentrum, Nordrhein-Westfalen
Ludgerus Clinic, Department of Cardiology, Clemens Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Patient Engagement

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

NCT ID

NCT04133350

First Posted

October 17, 2019

Last Updated

May 25, 2021

Sponsor

Thomas Jefferson University

Collaborators

Inova Fairfax Hospital, Heart and Diabetes Center North Rhine-Westphalia, CLEMENS HOSPITAL, Resmed Inc

1. Study Identification

Unique Protocol Identification Number

NCT04133350

Brief Title

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

Acronym

PEP-ASV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Terminated

Why Stopped

Inability to Recruit

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

February 1, 2021 (Actual)

Study Completion Date

February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thomas Jefferson University

Collaborators

Inova Fairfax Hospital, Heart and Diabetes Center North Rhine-Westphalia, CLEMENS HOSPITAL, Resmed Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Disorder; Breathing-Related, Heart Failure

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active Patient Engagement

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Active Patient Engagement

Intervention Description

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 Measure Information:

Title

Adherence (hours/night)

Description

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Quality of Life Score -

Description

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: Dyspnea at rest or with minimal exertion AND Treatment with at least one dose of IV diuretic or ultrafiltration AND 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: Right-sided heart failure without left-sided failure 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 Sustained systolic blood pressure <80 mmHg at baseline Complex congenital heart disease Constrictive pericarditis 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) Transient ischemic attack (TIA) or Stroke within 3 months prior to registry entry Definite clinically evident acute myocardial infarction within 3 months of registry entry Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas Moderate or greater valvular heart disease as the primary reason for heart failure In the opinion of the investigator, the index acute decompensated HF event was not due primarily to uncontrolled AFib with fast ventricular response rate Inability to comply with planned study procedures

Facility Information:

Facility Name

Thomas Jefferson University

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

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

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Facility Name

Herz- und Diabeteszentrum, Nordrhein-Westfalen

City

Bad Oeynhausen

State/Province

Ruhr-Universität Bochum

Country

Germany

Facility Name

Ludgerus Clinic, Department of Cardiology, Clemens Hospital

City

Münster

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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