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

NCT ID: NCT04629066

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2022-03-15

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Remote Cardiac Rehabilitation (CR)

Intervention Type: BEHAVIORAL

Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist.

The exercise prescription will change each week based on refreshed data from the prior week.

Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR.

Interventions

Remote Cardiac Rehabilitation (CR)

Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist.

The exercise prescription will change each week based on refreshed data from the prior week.

Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Evaluation System for health Technology Coordinating Center

OTHER

Sponsor Role: collaborator

Medical Device Innovation Consortium (MDIC)

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brett Atwater, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Pro00107053

Identifier Type: -

Identifier Source: org_study_id