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

Heart Failure Clinical Trial

— PEP-ASV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04133350
• Other study ID #: 19P.115
• Status: Terminated
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: May 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Sleep Disorder; Breathing-Related
• Sleep Wake Disorders

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.

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	CLEMENS HOSPITAL, Heart and Diabetes Center North Rhine-Westphalia, Inova Fairfax Hospital, Resmed Inc

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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