Clinical trial NCT04629066: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION
Official title: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (Pilot Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Remote Exercise Prescription
Cardiac Implant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Evaluation System for health Technology Coordinating Center
name: Medical Device Innovation Consortium (MDIC)
First posted: 2020-11-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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

Primary outcomes:
measure: Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA)
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score
timeFrame: Baseline to 12 weeks
measure: Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
timeFrame: Cumulative during 12 weeks of intervention
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score
timeFrame: 12 weeks after randomization
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Brett Atwater, MD
role: PRINCIPAL_INVESTIGATOR
References: