Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (Pilot Randomized Controlled Trial)

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
North Carolina
Duke University Medical Center
Durham
Time Frame
Start Date: April 27, 2021
Completion Date: March 15, 2022
Participants
Target number of participants: 8
Treatments
No Intervention: Usual care
Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.
Experimental: Remote prescription for aerobic exercise
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.
Related Therapeutic Areas
Sponsors
Collaborators: NESTcc, MDIC
Leads: Duke University

This content was sourced from clinicaltrials.gov

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