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

Duke University

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Remote Cardiac Rehabilitation (CR)

Study type: Interventional

Funder types: Other

Identifiers

NCT04629066

Pro00107053

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

13 participants in 2 patient groups

Usual care

No Intervention group

Description:

Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.

Remote prescription for aerobic exercise

Experimental group

Description:

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, and cardiac implant measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.

Treatment:

Behavioral: Remote Cardiac Rehabilitation (CR)