Trial Outcomes & Findings for Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (NCT NCT04629066)

NCT ID: NCT04629066

Last Updated: 2023-09-28

Results Overview

Reported in minutes of PA per day.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 weeks after randomization
• Results posted on: 2023-09-28

Participant Flow

Participant milestones

Measure	Usual Care Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	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.
Overall Study STARTED	7	6
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Usual Care Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	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.
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Usual Care n=7 Participants Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=6 Participants 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.	Total n=13 Participants Total of all reporting groups
Age, Continuous	68.0 years STANDARD_DEVIATION 8.89 • n=5 Participants	58.8 years STANDARD_DEVIATION 10.46 • n=7 Participants	63.8 years STANDARD_DEVIATION 10.38 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after randomization

Population: Data not collected on two participants.

Reported in minutes of PA per day.

Outcome measures

Measure	Usual Care n=5 Participants Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=6 Participants 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.
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	171.4 minutes per day Standard Deviation 74.59

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Data not collected on six participants.

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

Outcome measures

Measure	Usual Care n=3 Participants Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=2 Participants 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.
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score	5.2 score on a scale Standard Deviation 9.02	11.5 score on a scale Standard Deviation 16.20

SECONDARY outcome

Timeframe: Cumulative during 12 weeks of intervention

Outcome measures

Measure	Usual Care n=7 Participants Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=6 Participants 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.
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events	1 events	1 events

SECONDARY outcome

Timeframe: 12 weeks after randomization

Population: Data not collected on six participants.

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

Outcome measures

Measure	Usual Care n=3 Participants Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=2 Participants 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.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score	86.1 score on a scale Standard Deviation 14.63	93.8 score on a scale Standard Deviation 8.84

Adverse Events

Usual Care

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Remote Prescription for Aerobic Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Usual Care n=7 participants at risk Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=6 participants at risk 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.
Blood and lymphatic system disorders Stent Placement	14.3% 1/7 • Number of events 1 • Adverse Events were collected between consent and study completion, for a total of 13 weeks.	0.00% 0/6 • Adverse Events were collected between consent and study completion, for a total of 13 weeks.

Other adverse events

Measure	Usual Care n=7 participants at risk Usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team.	Remote Prescription for Aerobic Exercise n=6 participants at risk 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.
Musculoskeletal and connective tissue disorders Back injury	0.00% 0/7 • Adverse Events were collected between consent and study completion, for a total of 13 weeks.	16.7% 1/6 • Number of events 1 • Adverse Events were collected between consent and study completion, for a total of 13 weeks.

Additional Information

Marjan Cobbaert

Duke Clinical Research Institute

Phone: 919-668-9740

Email: mr157@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place