The HEARTFELT Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorHeartfelt Technologies
About this trial
This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are:
* Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives:
1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes.
Participants will need to:
* Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provision of signed and dated informed consent form (wet or digital signature)
Male or female, aged 22 to [No maximum age]
Diagnosed with Chronic Heart failure at least 2 months prior to randomization
Documented history of peripheral edema (edema in feet and lower legs), defined as at least one clinical mention in the medical record indicative of oedema during prior clinical assessment.
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Heartfelt Device installed
DeviceDevice installed in the patient's home and capturing foot volume data which are processed in the cloud.
Standard care
Other interventionRPMPs in regular contact with patients and collecting health monitoring data as per their standard operating procedures.
Heartfelt-guided care
DeviceVolume measurements and health alerts transmitted to the RPMP for review. RPMPs follow a pre-specified alert protocol, potentially following up with the patient.
Questionnaires
Other interventionPatients were presented with one or more optional questionnaires (some validated, some bespoke)
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Standard Care (control)Active comparator 3 interventions
Group B: Standard Care + Heartfelt (intervention)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Heart Failure Events (HFEs, a composite of HFH or Worsening HF event without hospitalization (as defined in [1-Abraham])
Used to demonstrate whether the device effectively reduces HFHs and urgent HF visits.
Time frame
12 months, plus up to 48 months long term follow-up2
Doubling in serum creatinine (sCr) from baseline with at least 2.0mg/dL
Used to ensure that increased diuretic treatment following alerts from the device does not lead to significant increase in AKI
Time frame
12 months, plus up to 48 months long term follow-upSecondary outcomes
1
Difference in data availability (device generated or contemporaneous self-report)
Used to measure the data availability from the Heartfelt device. One of the key findings from feasibility trials and pilot studies in the UK have demonstrated an increased data availability. Does this study in the US confirm the previous finding?
Time frame
12 months, plus up to 48 months long term follow-up2
The date and length (in hours) of hospital admission and re-admissions
Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Time frame
12 months, plus up to 48 months long term follow-up3
Cause of hospitalizations (HF or non-HF)
Used to review the lead time of health alerts, or the lack of health alerts generated prior to hospital admissions.
Time frame
12 months, plus up to 48 months long term follow-up4
Date of increase in HF medications when the patient is home or in the community (not the detailed changes whilst on the ward)
This may include oral diuretic, IV diuretics and subcutaneous furosemide injections. Used to allow the determination if an outpatient appointment is HF related or not.
Time frame
12 months, plus up to 48 months long term follow-upOther outcomes
1
NT Pro-BNP or BNP, with date if available in patient records
Used to correlate NT Pro-BNP health alert status.
Time frame
12 months, plus up to 48 months long term follow-up2
Date and time of health alerts from other monitoring devices
Used to correlate health alerts from other medical devices and the Heartfelt device.
Time frame
12 months, plus up to 48 months long term follow-up3
Symptoms diary (if available)
Used to establish patient usage of symptom diaries.
Time frame
12 months, plus up to 48 months long term follow-up4
Questionnaire responses (if available)
Used to establish patient acceptability of the device.
Time frame
12 months, plus up to 48 months long term follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov