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NCT04133350 · ClinicalTrials.gov registry record · NA

Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)

A NA study, sponsored by Thomas Jefferson University.

Terminated
Registry status
NA
Development phase
2
Enrollment target

NCT04133350: Clinical Trial NA study, sponsored by Thomas Jefferson University.

NCT04133350 is a NA study that was terminated before completion, run by Thomas Jefferson University. The registered enrollment target is 2 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04133350, a NA study, was terminated before completion, sponsored by Thomas Jefferson University.

TERMINATED
Registry status
NA
Development phase
2 participants
Enrollment target

Study 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.

Primary Outcome

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).

Interventions

  • BEHAVIORAL Active Patient Engagement

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2019-10-16
Est. Completion 2021-02-01
Phase NA
Thomas Jefferson University

292 total trials

Why NCT04133350 stopped before completion

NCT04133350 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Active Patient Engagement is the first listed.

NCT04133350 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04133350 about?

NCT04133350 is a clinical study titled "Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)". 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...

What is the current status of trial NCT04133350?

This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2019-10-16. Estimated completion is 2021-02-01.

What interventions are being tested in trial NCT04133350?

The interventions under investigation include: Active Patient Engagement (BEHAVIORAL).

Who is sponsoring clinical trial NCT04133350?

This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04133350's enrollment target sits among peer trials

2 1997th of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04133350, the US trial registry maintained by the National Library of Medicine. NCT04133350 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.