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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Remote Cardiac Rehabilitation (CR)

• Registration Number: NCT04629066
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-16
• Study Start: 2021-04-27
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Results First Submitted: 2022-09-12
• Results First Submitted QC: 2022-09-12
• Results First Posted: 2023-08-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote prescription for aerobic exercise	Remote Cardiac Rehabilitation (CR)	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.

Primary Outcome Measures

Name	Time	Method
Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA)	12 weeks after randomization	Reported in minutes of PA per day.

Secondary Outcome Measures

Name	Time	Method
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score	Baseline to 12 weeks	The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events	Cumulative during 12 weeks of intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score	12 weeks after randomization	The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States