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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Cardiac Rehabilitation (CR)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring Remote Exercise Prescription, Cardiac Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Remote prescription for aerobic exercise

Arm Description

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, and cardiac implant measures of physical activity, heart rate, heart failure volume status and heart rhythm, and Fitbit measures of physical activity.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score
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
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score
The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.

Full Information

First Posted
November 2, 2020
Last Updated
September 20, 2023
Sponsor
Duke University
Collaborators
National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC)
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1. Study Identification

Unique Protocol Identification Number
NCT04629066
Brief Title
Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION
Acronym
x
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Evaluation System for health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Remote Exercise Prescription, Cardiac Implant

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.
Arm Title
Remote prescription for aerobic exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Cardiac Rehabilitation (CR)
Intervention Description
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 Outcome Measure Information:
Title
Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA)
Description
Reported in minutes of PA per day.
Time Frame
12 weeks after randomization
Secondary Outcome Measure Information:
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score
Description
The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.
Time Frame
Baseline to 12 weeks
Title
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
Time Frame
Cumulative during 12 weeks of intervention
Title
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score
Description
The KCCQ has a range of 0 to 100, where a higher score indicates a more favorable health status.
Time Frame
12 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Atwater, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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