Heart failure & cardiomyopathiesRandomised controlled trial
Risk-Based Nurse-Managed Personalized Heart Failure Interventions
- Randomised controlled trial
- 1:1 randomisation
Authors' conclusion
ICM-based risk status detection with centrally coordinated diuretic intervention was safe and yielded a neutral result for the primary composite outcome under the tested implementation strategy
Study context
- Population
- Participants with heart failure (HF) implanted with a Reveal LINQ insertable cardiac monitor (ICM) with investigational HF risk-status softwarerandomized
- Participants
- 711 participants
- Comparison
- Intervention vs Observation
- Interventionn = 357
- Observationn = 354reference
- Primary endpoint
- Efficacy: 5-component hierarchical composite (CV death, HF hospitalization or outpatient HF event within 60 days of high-risk onset, KCCQ Clinical Summary Score, 6-minute walk distance), analysed by win ratio; safety: intervention-related serious adverse events
Primary result
As reported in the abstract
5-component hierarchical composite (CV death, HF hospitalization or outpatient HF event within 60 days of high-risk onset, KCCQ Clinical Summary Score, 6-minute walk distance)
Primary composite did not significantly differ between groups (win ratio)
0.79; 95% CI: 0.62-1.01; P = 0.06
Further findings
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Cumulative CV death and HF events · mean follow-up 17.3 ± 8.9 months · numerically higher with intervention | 1.43 (0.95–2.15) | P = 0.091 | |
| 0.512Hazard ratio (log scale) |
Primary composite, adjusted for baseline KCCQ imbalance (exploratory sensitivity analysis)
- Win ratio after adjustment for baseline KCCQ imbalance
- 1.02 (95% CI: 0.80-1.31; P = 0.85)
- exploratory sensitivity analysis
Safety
Serious adverse events (primary safety endpoint) · mean follow-up 17.3 ± 8.9 months
- Serious adverse events rate
- 0.32% (95% CI: 0.10%-0.99%)
- prespecified safety threshold ≤5%
Original publication
Risk-Based Nurse-Managed Personalized Heart Failure Interventions. J Am Coll Cardiol. Published 27 May 2026. doi:10.1016/j.jacc.2026.03.075
Summarised from the published abstract; every number is checked against it