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Completed

NCT Number: NCT04629066

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Cardiac Rehabilitation (CR)

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.

Primary outcomes

  1. Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA)

    Time frame: 12 weeks after randomization

    Reported in minutes of PA per day.

Secondary outcomes

  1. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score

    Time frame: Baseline to 12 weeks

    The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.

  2. Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events

    Time frame: Cumulative during 12 weeks of intervention

  3. Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score

    Time frame: 12 weeks after randomization

    The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Medical Device Innovation Consortium (MDIC)
  • National Evaluation System for health Technology Coordinating Center

Registry information

Official study title

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

Acronym: x

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2020
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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