Loading clinical trials...

Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV) | Clinical Trials | Clareo Health

TERMINATEDNA

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

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

NCT04133350•Thomas Jefferson University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

•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
+2 more criteria

Locations (4)

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

Key Dates

Start Date

October 16, 2019

Primary Completion Date

February 1, 2021

Completion Date

February 1, 2021

Last Updated

May 27, 2021

Enrollment

ACTUAL participants

Conditions

Sleep Disorder; Breathing-RelatedHeart Failure

Interventions

Active Patient Engagement

BEHAVIORAL

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

RECRUITINGNA

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation