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Evaluation of mobile health technology combining telemonitoring and teleintervention versus usual care in vulnerable-phase heart failure management (HERMeS): a multicentre, randomised controlled trial.

The Lancet. Digital health2025-05-16PubMed
Total: 87.0Innovation: 8Impact: 0Rigor: 0Citation: 0

Summary

In the HERMeS phase 3 trial of 506 recently discharged heart failure patients, a telemonitoring plus structured teleintervention program reduced the composite of cardiovascular death or worsening heart failure versus usual care (HR 0.35). Benefits were observed over 6 months without reported safety signals. Findings support integrating mHealth into transitional HF care.

Key Findings

  • Composite of cardiovascular death or worsening heart failure reduced with mHealth vs usual care (17% vs 41%; HR 0.35, 95% CI 0.24–0.50).
  • Randomized 1:1, 506 adults post HF decompensation; follow-up 24 weeks.
  • No spontaneously reported harms; consistent benefit across the vulnerable phase.

Clinical Implications

Supports routine integration of telemonitoring plus structured remote follow-up in early post-discharge HF pathways to reduce cardiovascular death and decompensation.

Why It Matters

First robust RCT to demonstrate event reduction using combined telemonitoring and teleintervention during the vulnerable post-discharge phase of heart failure.

Limitations

  • Open-label design could introduce behavioral or care biases
  • Conducted within one country’s health system, which may affect generalizability

Future Directions

Validate across diverse healthcare systems, assess cost-effectiveness, and delineate which teleintervention components drive the effect.

Study Information

Study Type
RCT
Research Domain
Treatment
Evidence Level
I - Randomized controlled, phase 3 multicenter trial with masked endpoint adjudication.
Study Design
OTHER