NCT04133350

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

October 17, 2019

Last Update Submit

May 25, 2021

Conditions

Sleep Disorder; Breathing-RelatedHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Adherence (hours/night)

    Demonstrate acceptable adherence to ASV therapy can be achieved in patients with moderate to severe SDB in a recently hospitalized population of Heart Failure patients with preserved ejection fraction (HFpEF).

    3 months

Secondary Outcomes (1)

  • Quality of Life Score -

    3 months

Study Arms (1)

Active Patient Engagement

EXPERIMENTAL

All patients are enrolled into the Active Patient Engagement (APE) arm. This arm will receive the APE intervention.

Behavioral: Active Patient Engagement

Interventions

Active Patient EngagementBEHAVIORAL

The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.

Active Patient Engagement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

INOVA (Inova Heart and Vascular Institute, Inova Fairfax Hospital)

Falls Church, Virginia, 22042, United States

Location

Herz- und Diabeteszentrum, Nordrhein-Westfalen

Bad Oeynhausen, Ruhr-Universität Bochum, Germany

Location

Ludgerus Clinic, Department of Cardiology, Clemens Hospital

Münster, Germany

Location

MeSH Terms

Conditions

Sleep Wake DisordersHeart Failure

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2019

First Posted

October 21, 2019

Study Start

October 16, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations

US(2)DE(2)