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

NCT03195660 | Terminated Results FDA Device

• 1 other identifier: MA-16-12-01
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Heart Failure With Normal Ejection Fraction; Sleep Apnea

Keywords

adaptive servo-ventilation; ASV; HFpEF

Outcome Measures

Primary Outcomes (1)

• ASV Adherence

  Average hours used per day

  3 months

Secondary Outcomes (3)

• KCCQ-12

  3 months

• Hospitalizations

  3 months

• Death

  3 months

Study Arms (1)

ASV Therapy

EXPERIMENTAL

ASV Therapy

Device: ASV Therapy

Interventions

ASV Therapy DEVICE

AirCurve 10 ASV device set up in AutoSet mode

Also known as: AirCurve 10 ASV

ASV Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ResMed: lead

Study Sites (4)

University of California San Diego

San Diego, California, 92123, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Heart and Diabetes Center - West Rhine-Westphalia

Bad Oeynhausen, Germany

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

Study was terminated early; results were not analyzed. Six participants overall were consented for the study; four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.

Results Point of Contact

• Title: Adam Benjafield
• Organization: ResMed

adam.benjafield@resmed.com

+61 466 634 609

Study Officials

• Christopher O'Connor, MD

  Inova Heart and Vascular Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single-arm, un-blinded, multi-center

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: June 26, 2017
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: May 14, 2021
• Results First Posted: May 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); DE (1)