Heartfelt Edema Monitor Improves HF Outcomes, May Provide Durable Benefit

Ambient, at-home monitoring of patients with peripheral edema due to congestive heart failure (HF) resulted in a potentially significant reduction in recurrent HF events and a potentially durable carry-over effect, according to the HF-TRACK study.¹

These data were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026 in Phoenix, Arizona, by John Cleland, MD, PhD, emeritus professor at the University of Glasgow. In an exclusive interview with HCPLive, Cleland discusses the implications of this new monitoring technology and the benefits it may provide for patients with HF.¹

“Our novel monitoring device was to assess leg volumes, which it could do passively. Unlike conventional monitoring, where the patient is required to make measurements, with this device, the measurements are made automatically,” Cleland told HCPLive. “Of course, we know that many patients with HF are poorly compliant with monitoring requests, so this obviates the need for these actions on the part of the patient.”

HF-TRACK was a randomized controlled trial evaluating the effectiveness of an inclusive heart failure monitoring and tracking solution in the UK. Patients were eligible for inclusion if they had a diagnosis of HF ≥3 months prior, peripheral edema reported on ≥1 HF-related hospitalization within the last 4 years, were receiving diuretics on a daily basis, and had been hospitalized for HF within the last 12 months, among other criteria. Patients who had undergone amputation of both feet, regularly used a wheelchair in their home, or were bed-bound, among other criteria, were excluded from the trial.²

The primary outcome measures were the rate of all-cause mortality, the rate of device-related complications, and the incidence of HF events. Secondary outcome measures included cause and date of death, hospital admission duration, cause of hospitalization, loss of independence, date of changes in HF medication after discharge, and changes in HF medication dosing post-discharge, among others.²

A total of 186 patients with chronic HF were enrolled in the trial, with 91 assigned to the control group first and 95 to the Heartfelt group first. Among these patients, Cleland and colleagues saw 9 events occur in the treatment group compared to 19 in the control group (HR, 0.47; 90% CI; P = .0524), and the control group also had significantly shorter time to first event on average (7 vs. 13 events; HR, 0.54; 90% CI; P = .1207).¹

Comparatively, there were fewer HF events in both the Heartfelt and control groups over time after installation. In his presentation, Cleland noted the potentially durable effect of the Heartfelt device, implying a possible duration of roughly 30 days. There were also no adverse or serious adverse events associated with the device.¹

Cleland and colleagues ultimately determined that the use of the Heartfelt monitor may be extremely efficacious in this population, leading to fewer deaths and HF events while maintaining a considerable durability of effect. However, the team also notes the need for further long-term research to evaluate the full efficacy of the device, which is already underway.^1,2

“This device could well be complementary to pressure monitoring devices,” Cleland said. “However, on the other hand, this could be quite a cost-effective solution and, compared to some of the very high-end implantable pressure monitoring devices, this should be much more affordable.”

Editors’ Note: Cleland reports disclosures with Abbott, Bayer, Boehringer-Ingelheim, Medtronic, Novartis, Pharmacosmos, and others.

References

1. Castiello T, Cleland J, Salahshouri P. Ambient Home Monitoring of Peripheral Oedema Significantly Reduces Heart Failure Events: Final Results from the Randomized HF-TRACK Trial. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

2. Heartfelt Technologies. HF-TRACK: A UK RCT of a Passive Heart Failure Monitoring and Tracking Device (HF-TRACK). ClinicalTrials.gov Identifier: NCT06334822. Updated April 16, 2026. Accessed November 2, 2026. https://clinicaltrials.gov/study/NCT06334822?term=NCT06334822&rank=1