Heart Failure
Conditions
Keywords
Remote Exercise Prescription, Cardiac Implant
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.
Interventions
BEHAVIORALRemote 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.
Sponsors
National Evaluation System for health Technology Coordinating Center
Medical Device Innovation Consortium (MDIC)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. | 7 |
| 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.
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. | 6 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
Baseline characteristics
| Characteristic | Usual Care | Remote Prescription for Aerobic Exercise | Total |
|---|---|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 8.89 | 58.8 years STANDARD_DEVIATION 10.46 | 63.8 years STANDARD_DEVIATION 10.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 1 / 6 |
| serious Total, serious adverse events | 1 / 7 | 0 / 6 |
Outcome results
Primary
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.
Time frame: 12 weeks after randomization
Population: Data not collected on two participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA) | 129.3 minutes per day | Standard Deviation 77.96 |
| Remote Prescription for Aerobic Exercise | Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA) | 171.4 minutes per day | Standard Deviation 74.59 |
Secondary
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.
Time frame: Baseline to 12 weeks
Population: Data not collected on six participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score | 5.2 score on a scale | Standard Deviation 9.02 |
| Remote Prescription for Aerobic Exercise | Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score | 11.5 score on a scale | Standard Deviation 16.2 |
Secondary
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.
Time frame: 12 weeks after randomization
Population: Data not collected on six participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score | 86.1 score on a scale | Standard Deviation 14.63 |
| Remote Prescription for Aerobic Exercise | Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score | 93.8 score on a scale | Standard Deviation 8.84 |
Secondary
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
Time frame: Cumulative during 12 weeks of intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events | 1 events |
| Remote Prescription for Aerobic Exercise | Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events | 1 events |