Pragmatic Crossover Trial Targets Non-Adherent Heart Failure Patients: Passive Peripheral Edema Monitoring vs Conventional Remote Care in 1,500-Patient Study
247 Health News Editorial
·3 July 2026
·5 min read
·clinical-trialsA 1,500-patient pragmatic crossover trial is testing whether passive, camera-based peripheral oedema monitoring using the Heartfelt device can reduce heart failure hospitalisations in patients with documented non-adherence to conventional remote monitoring programmes. The trial, recruiting now across US sites, targets one of the most clinically challenging and underserved subpopulations in heart failure management — those least able to sustain active self-monitoring.
Originally reported by ClinicalTrials.gov
References
- 1.Heartfelt Technologies. (2024). A pragmatic, single-blind, randomized crossover trial testing the effectiveness of autonomous remote patient peripheral edema monitoring and reporting in HEART FailurE compared to conventionaL remoTe patient monitoring (HEART-FELT) (NCT06222099). ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT06222099
- 2.Abraham, W. T., Stevenson, L. W., Bourge, R. C., Lindenfeld, J. A., Bauman, J. G., & Adamson, P. B. (2016). Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: Complete follow-up results from the CHAMPION randomised trial. The Lancet, 387(10017), 453–461. https://doi.org/10.1016/S0140-6736(16)30216-5
- 3.Inglis, S. C., Clark, R. A., Dierckx, R., Prieto-Merino, D., & Cleland, J. G. (2015). Structured telephone support or non-invasive telemonitoring for patients with heart failure. Cochrane Database of Systematic Reviews, 2015(10), CD007228. https://doi.org/10.1002/14651858.CD007228.pub3
- 4.Mant, J., Ledger, J., & Griffith, L. (2022). Remote monitoring in heart failure: Current evidence and future directions. Heart, 108(12), 938–944. https://doi.org/10.1136/heartjnl-2021-319825
- 5.McDonagh, T. A., Metra, M., Adamo, M., Gardner, R. S., Baumbach, A., Böhm, M., Burri, H., Butler, J., Čelutkienė, J., Chioncel, O., Cleland, J. G. F., Coats, A. J. S., Crespo-Leiro, M. G., Farmakis, D., Gilard, M., Heymans, S., Hoes, A. W., Jaarsma, T., Jankowska, E. A., … ESC Scientific Document Group. (2021). 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. European Heart Journal, 42(36), 3599–3726. https://doi.org/10.1093/eurheartj/ehab368
- 6.Savarese, G., Becher, P. M., Lund, L. H., Seferovic, P., Rosano, G. M. C., & Coats, A. J. S. (2023). Global burden of heart failure: A comprehensive and updated review of epidemiology. Cardiovascular Research, 118(17), 3272–3287. https://doi.org/10.1093/cvr/cvac013
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247 Health News Editorial
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