Passive peripheral oedema monitoring reduces recurrent heart failure events in a randomised crossover trial (HF-TRACK)

Background

Recurrent heart failure (HF) events drive morbidity, mortality, and healthcare utilisation1. Weight-based remote monitoring is limited by poor long-term adherence. Automated, passive monitoring of peripheral oedema2 may enable earlier detection of decompensation without requiring active patient engagement to collect remote patient monitoring physiological data.

Purpose

To estimate the effect size of automated peripheral oedema monitoring with health alerts on recurrent HF events in high-risk patients with chronic HF.

Methods

HF-TRACK (NCT06334822) is a UK-based randomised controlled crossover trial enrolling patients with chronic HF enriched for prior decompensation and poor adherence to daily weighing. Participants underwent two 3-month treatment periods (standard care vs. standard care plus automated device alerts).

The primary efficacy endpoint was recurrent HF events (hospitalisation or urgent HF treatment), adjudicated and analysed using Andersen–Gill Cox proportional hazards models with robust variance clustered by participant. A time-to-first event sensitivity analysis was also performed.

Results

Adherence to daily weighing was low, with a median of 0.2 days of weight data per week. In contrast, passive oedema monitoring provided substantially greater data availability (median 4.7 days per week).

At the interim analysis, 31 HF events occurred during treatment periods (control 20; intervention 11). Automated alerting was associated with a 47% reduction in recurrent HF events compared with control (HR 0.53, 95% CI 0.27–1.03; p=0.0596). Time-to-first HF event analysis was consistent (HR 0.51, 95% CI 0.25–1.03; p=0.0604), with 23 first HF-events (control 15; intervention 8). Mean cumulative function analysis demonstrated sustained divergence in total HF burden across treatment periods.

No safety signal was observed.

Participants experiencing unscheduled events were older, had a greater comorbidity burden, and demonstrated lower adherence scores than those without events.

Before enrolment, fewer patients who later experienced HF hospitalisation had been weighing regularly, despite reporting similar confidence in recognising congestion. Only 40% identified daily weighing as important for HF self-management prior to study entry, despite guideline recommendations.

At baseline, participants who subsequently experienced HF-events reported greater symptom burden and more severe peripheral oedema. Across the cohort, EQ-5D domains most affected were mobility, pain/discomfort, and anxiety/depression.

Participants preferred passive oedema monitoring over scales, wearables, or implantable systems (all p<0.05).

Conclusion

In this randomised crossover trial of high-risk HF patients, passive automated peripheral oedema monitoring with health alerts was associated with a clinically meaningful reduction in recurrent HF events compared with standard care.Data availabilityHFE burden and time to first event