Heart FailurexNCT04629066
Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION
A study testing Remote Cardiac Rehabilitation (CR) in people with Heart Failure, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Remote Cardiac Rehabilitation (CR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 15 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (Pilot Randomized Controlled Trial)
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.
- Conditions
- Heart Failure
- Being tested
- Remote Cardiac Rehabilitation (CR)
- Keywords
- Remote Exercise Prescription, Cardiac Implant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Cardiac Rehabilitation (CR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | 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 | Experimental | 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. Receives: Behavioral: Remote Cardiac Rehabilitation (CR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after randomization
Secondary outcomes (3)
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.
Measured: Baseline to 12 weeks
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
Measured: Cumulative during 12 weeks of intervention
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.
Measured: 12 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start27 Apr 2021
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Evaluation System for health Technology Coordinating Center, Medical Device Innovation Consortium (MDIC)
- Responsible party
- Sponsor
- Investigators
- Brett Atwater, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629066
- Sponsor's protocol ID
- Pro00107053
- Acronym
- x
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2020
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of ICD Remote Monitored Exercise Testing to Improve Heart Failure Outcomes: REMOTE HF-ACTION (Pilot Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04629066
- Acronym / sponsor ID
- x / Pro00107053
- Conditions
- Heart Failure
- Keywords
- Remote Exercise Prescription, Cardiac Implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Evaluation System for health Technology Coordinating Center, Medical Device Innovation Consortium (MDIC)
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –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 | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Remote prescription for aerobic exercise |
Primary outcome
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.
3 secondary outcomes
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptoms Severity Score
Time frame: Baseline to 12 weeks
Number of Heart Failure Hospitalization, Fracture, Myocardial Infarction, Serious Adverse Arrhythmia, and ICD Therapy Combination Events
Time frame: Cumulative during 12 weeks of intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ) Heart Failure (HF) Symptom Severity Score
Time frame: 12 weeks after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett Atwater, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Cardiac Rehabilitation (CR) in people with Heart Failure, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abbott Implantable Cardioverter-defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) Device Measured Daily Physical Activity (PA) (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.