Heart Failure Clinical Trial
Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study
Summary
This study is designed to demonstrate feasibility of study conduct and that acceptable adherence to adaptive servo-ventilation (ASV) therapy can be achieved in recently hospitalized HFpEF patients with moderate to severe sleep apnea. All subjects meeting the criteria will receive ASV therapy.
Full Description
Cardiovascular Improvements with Minute Ventilation-targeted ASV Therapy in Heart Failure Study (CAT-HF) was a randomized controlled clinical trial in the United States and Germany. It was designed to evaluate the effect of ASV in hospitalized heart failure (HFrEF and HFpEF) patients on a global rank endpoint of survival free from CV hospitalization and improvement in functional capacity measured by 6-minute walk distance. Analysis of the 126 subjects that were randomized showed a neutral result for the primary endpoint; however, in the pre-specified analysis of the primary endpoint by LVEF strata, there was a favorable statistically significant difference in the HFpEF subgroup (p=0.036).
Although the CAT-HF study showed a positive signal in the HFpEF subgroup, these patients represented a small percentage of the randomized subjects in the study. The current study aims to show that by applying newer technologies to support adherence, as well as focusing on the lessons learned in CAT-HF to identify and recruit HFpEF patients, acceptable adherence to ASV therapy can be achieved in HFpEF patients.
Eligibility Criteria
Inclusion Criteria:
Patients 18 years or older
Patients with heart failure with preserved ejection fraction (HFpEF; LVEF ≥50%)
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: A. No current atrial fibrillation (AFib): BNP≥100 pg/mL or NT pro- BNP≥300 pg/mL OR B. Current AFib: BNP≥150 pg/mL or NT pro-BNP≥450 pg/mL
Sleep disordered breathing (SDB) documented by screening polygraphy with an AHI≥15 events/hour (e/hr)
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 study entry) of any PAP therapy (eg, 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 study entry
Definite clinically evident acute myocardial infarction within 3 months of study entry
Known amyloidosis, hypertrophic obstructive cardiomyopathy, or arteriovenous fistulas
Moderate or greater valvular heart disease as the primary reason for heart failure
Pregnant, or planning to become pregnant during the study period
In the opinion of the investigator, the index acute decompensated HF event was due primarily to uncontrolled AFib with fast ventricular response rate
Inability to comply with planned study procedures
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There are 3 Locations for this study
San Diego California, 92123, United States
Philadelphia Pennsylvania, 19107, United States
Falls Church Virginia, 22042, United States
Bad Oeynhausen , , Germany
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