Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

Stopped early · Not applicable

Conditions studied: Heart Failure With Normal Ejection Fraction, Sleep Apnea

In brief

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.

Key facts

Study ID

NCT03195660

Run by

ResMed

People needed

6

Starts

2017-06-26

Expected to finish

2017-11-15

Last updated by the study team

2021-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego — San Diego, California, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• Heart and Diabetes Center - West Rhine-Westphalia — Bad Oeynhausen, Germany

Full record on ClinicalTrials.gov

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