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NCT04629066 · ClinicalTrials.gov registry record · NA

Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
13
Enrollment target

NCT04629066 is a NA study that has completed, run by Duke University. The registered enrollment target is 13 participants.

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The verdict

NCT04629066, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
13 participants
Enrollment target

Study Summary

This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin remote patient monitoring network. Patients will be randomized in a 1:1 fashion to usual care plus a remotely administered home based weekly prescription for aerobic exercise (intervention) or usual care alone (control). Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. The exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing HF symptom severity, vital signs, weight, and blood sugar, implantable device measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.

Interventions

  • BEHAVIORAL Remote Cardiac Rehabilitation (CR)

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2021-04-27
Est. Completion 2022-03-15
Phase NA

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT04629066

The ClinicalTrials.gov registry entry for NCT04629066 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Remote Cardiac Rehabilitation (CR) is the first listed.

NCT04629066 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04629066 about?

NCT04629066 is a clinical study titled "Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION". This single center randomized controlled trial will involve 50 medically stable outpatients with HF, reduced ejection fraction, and previously implanted ICD or CRT-D devices followed longitudinally on the Abbott Medical Merlin remote patient monitoring network. Patients will be randomized in a 1:1 f...

What is the current status of trial NCT04629066?

This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2021-04-27. Estimated completion is 2022-03-15.

What interventions are being tested in trial NCT04629066?

The interventions under investigation include: Remote Cardiac Rehabilitation (CR) (BEHAVIORAL).

Who is sponsoring clinical trial NCT04629066?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.