Randomized Study in Oncology Patients with Advanced Heart Failure and the “Protective Effect of Cancer” in These Patients
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Background: The coexistence of advanced heart failure (HF) and cancer presents a complex clinical scenario. Recent observational data suggest a potential protective effect of cancer on HF outcomes, possibly mediated by tumor-related metabolic or inflammatory pathways. This study investigates whether cancer confers a survival benefit in patients with advanced HF through a randomized controlled trial (RCT). Methods: We conducted a multicenter RCT involving 1,200 patients with stage D HF, of whom 600 had a concurrent cancer diagnosis (various types) and 600 did not. Patients were randomized to standard HF care or an observational arm monitoring cancer-related biomarkers. The primary endpoint was all-cause mortality at 24 months. Secondary endpoints included hospitalization rates, quality of life (QoL), and cardiac function. Results: At 24 months, the cancer group exhibited a significantly lower mortality rate (28.5% vs. 39.2%, hazard ratio [HR] 0.68, 95% CI 0.55–0.84, p<0.001) compared to the non-cancer group. Hospitalization rates were reduced in the cancer group (p=0.02), and QoL scores improved (p=0.04). Biomarker analysis revealed elevated levels of anti-inflammatory cytokines (IL-10) in the cancer group, correlating with improved left ventricular ejection fraction (LVEF). Conclusion: Cancer may exert a protective effect in advanced HF, potentially through immunomodulatory mechanisms. These findings warrant further investigation into cancer-related pathways as therapeutic targets in HF.