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
Qualifiers
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
Treatments tested in this trial
- Heartfelt Device installed
- Standard care
- Heartfelt-guided care
- Questionnaires
Treatment groups
1,500 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov