Clinical trial NCT04133350: Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (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
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Disorder; Breathing-Related
Heart Failure
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Inova Fairfax Hospital
name: Heart and Diabetes Center North Rhine-Westphalia
name: CLEMENS HOSPITAL
name: Resmed Inc
First posted: 2019-10-21
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Adherence (hours/night)
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life Score -
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Falls Church
country: United States
facility: INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)
state: Virginia
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum, Nordrhein-Westfalen
state: Ruhr-Universität Bochum
city: Münster
country: Germany
facility: Ludgerus Clinic, Department of Cardiology, Clemens Hospital
Study officials:
References: