Health Technology/clinical-trials

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

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3 July 2026

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5 min read

·clinical-trials

A 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. 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. 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. 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. 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. 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. 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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