Heart Failure Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients have a MERLIN patient registry record for an ICD or CRT-D implantation between 01/01/2010-12/31/2020
Age > 18 years
Left ventricular ejection fraction < 50% by echocardiogram, nuclear cardiology scan, cardiac magnetic resonance imaging, or invasive left ventriculography within the past 12 months.
Ongoing NYHA class II, III, or IV HF symptoms by questionnaire
Ongoing use of beta-blocker and ACE-inhibitor or angiotensin receptor blocker or willingness to start them- assessed by Duke Epic EMR screening.
Life expectancy > 12 months
To allow for a post-surgical adjustment period, patients must be >30 days out from device implantation

Exclusion Criteria:

Prior participation in CR- by patient questionnaire
Unwillingness to sign informed consent form
Currently performing > 240 minutes of device detected daily PA- by ICD/CRTD remotely collected data.
Lack of a smartphone or unwillingness to use an App or Fitbit device
Prior left ventricular assist device (LVAD) implantation or heart transplantation
ICD tachyarrhythmia therapies programmed off
Inherited arrhythmia condition with contraindication to exercise (eg Lamin A mutation or ARVC)
No transmissions through Merlin.net in past 12 months

Study is for people with:

Heart Failure

Estimated Enrollment:

13

Study ID:

NCT04629066

Recruitment Status:

Completed

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

13

Study ID:

NCT04629066

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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