Trial reportESC heart failure2026
Comprehensive clinical benefit of CCM in HFrEF patients: a win-ratio analysis of FIX-HF-5C randomized trial.
Trial report in ESC heart failure, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
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Authors and funding
8 authors.
Funding
Abstract
backgroundFIX-HF-5C multicentre, randomized study demonstrated cardiac contractility modulation (CCMTM) improved patient-centred outcomes, including functional capacity, symptom burden, and health-related quality of life. Reductions in cardiovascular death and heart failure hospitalization (HFH) were observed. These event-driven outcomes were not prespecified efficacy endpoints and were not incorporated into overall assessment of treatment benefit. Comprehensive clinical benefit of CCM therapy was re-analyzed by a win-ratio method that integrated event-driven clinical endpoints with patient-centred outcomes.
methodsThe hierarchical win-ratio prioritized cardiovascular mortality, HFH, and patient-centred outcomes comprising equally weighted components of peak oxygen consumption, Minnesota Living with Heart Failure Questionnaire score, 6-minute walk distance, and NYHA functional class. Sub-group analyses were performed in patients with NYHA Class III versus IV.
resultsIn the primary analysis of 160 randomized patients (6364 patient pairs), the overall win ratio was 2.48 (95% CI 1.76 to 3.64; P < .001), corresponding to a 71% pairwise comparative probability of clinical benefit with CCM versus OMT. Event-driven clinical endpoints accounted for 22% of total wins while 56.2% came from patient-centric endpoints. CCM consistently outperformed OMT across all hierarchies. Sensitivity analyses yielded similar findings with win ratios favouring CCM (range: 1.52 to 2.42). Treatment effects were consistent across NYHA class III and IV subgroups.
conclusionsThe win-ratio re-analysis supports and extends the original study results demonstrating a consistent clinical benefit of CCM therapy over OMT across a hierarchical framework integrating event-driven clinical endpoints with patient-centred functional outcomes. The findings, while clinically highly encouraging, are hypothesis-generating and warrant validation in future confirmatory studies.
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