UF-CARE-trial: ultrafiltratie bij type-2 cardiorenaal syndroom geen significante winst (kleine, onderpowered RCT)

BACKGROUND: Type 2 cardiorenal syndrome (CRS), characterized by chronic heart failure (HF) leading to chronic kidney disease (CKD), is associated with high morbidity and mortality. In patients with refractory congestive HF, extrarenal fluid removal techniques can be proposed. We aimed to evaluate whether adding ultrafiltration through peritoneal dialysis (PD), haemodialysis (HD) or isolated ultrafiltration (IUF) improves clinical outcomes compared with optimized medical therapy alone. METHODS: UF-CARE was a multicentre, randomized, controlled, open-label trial conducted in 15 French centres. Adults with severe HF, persistent or recurrent congestion despite high-dose diuretics and guideline-directed medical therapy, and mild to severe CKD were randomized to optimized medical therapy alone (Control group) or optimized medical therapy plus ultrafiltration (Ultrafiltration group), through PD, HD or IUF, according to clinical judgment, patient characteristics and preferences, and availability in each centre. The primary outcome was a composite of all-cause mortality or unplanned hospitalization for acute HF within 12 months. RESULTS: Among 108 screened patients, 46 were randomized (24 Control group, 22 Ultrafiltration group). After a median follow-up of 262 days, the primary outcome occurred in 63% of patients in the Ultrafiltration group and 87% in the Control group (p = 0.144). Quality-of-life scores seemed to improve over time in both groups, with a slightly more sustained improvement in the ultrafiltration group. One death related to the technique was reported. CONCLUSION: In patients with type 2 CRS and refractory congestive HF, adding ultrafiltration through PD, HD or IUF did not significantly reduce mortality or HF-related hospitalizations at 12 months compared with optimized medical therapy and close multidisciplinary follow-up, although the trial was underpowered. CLINICAL TRIAL REGISTRATION: NCT02846337.