Status:
TERMINATED
Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Inova Fairfax Hospital
Heart and Diabetes Center North Rhine-Westphalia
Conditions:
Sleep Disorder; Breathing-Related
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 disordere...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04133350
Start Date
October 16 2019
End Date
February 1 2021
Last Update
May 27 2021
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
2
INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)
Falls Church, Virginia, United States, 22042
3
Herz- und Diabeteszentrum, Nordrhein-Westfalen
Bad Oeynhausen, Ruhr-Universität Bochum, Germany
4
Ludgerus Clinic, Department of Cardiology, Clemens Hospital
Münster, Germany