ESC heart failure · 2026
The effect of a change in fluid intake advice on outcomes in chronic heart failure: a prespecified subanalysis of the FRESH-UP study.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Herrmann Job J, Brunner-La Rocca Hans-Peter, Baltussen Lisette E H J M, Beckers-Wesche Fabienne, Bekkers Sebastiaan C A M, Bellersen Louise, Van Eck J W Martijn, Hassing H Carlijne, Jaarsma Tiny, Linssen Gerard C M, Pisters Ron, Sanders-Van Wijk Sandra, Verdijk Marjolein H I, Rodwell Laura, van Kimmenade Roland R J, Gommans D H Frank
Аннотация
BACKGROUND AND AIMS: The Fluid REStriction in Heart failure versus liberal fluid UPtake (FRESH-UP) study (NCT04551729) randomized patients with chronic heart failure (HF) to liberal fluid intake (LFI) vs fluid restriction (FR). Pre-trial fluid management may have impacted trial outcomes.
METHODS: The open-label FRESH-UP study randomized 504 patients with chronic HF to an advice of LFI or FR of 1500 ml/day. Primary outcome was the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) after 3 months adjusted for baseline. Key secondary outcome was thirst distress. Patient-reported fluid intake was assessed at Week 6. Safety outcomes included death and hospitalizations. For this subanalysis, participants were stratified according to pre-trial fluid management (FR or LFI).
RESULTS: Prior to randomization, 269 (53.4%) patients adhered to FR and 235 (46.6%) adhered to LFI. After 3 month follow-up, KCCQ-OSS was significantly different between groups (P = .035): in patients changing from pre-trial FR to LFI, KCCQ-OSS was 74.7 [95% confidence interval (CI) 71.2-78.3] compared to 70.2 (95% CI 66.3-74.2) in those with the reversed scenario. In the latter group, thirst distress increased the most. Patient-reported fluid intake was significantly higher in patients randomized to LFI when compared to FR (P = .019), regardless of pre-trial FR or LFI (1771 and 1757 ml, vs 1486 and 1464 ml, respectively). Safety outcomes did not differ.
CONCLUSIONS: These analyses add understanding to the effects of fluid intake management in chronic HF and expose a signal of potential harm of FR in patients with pre-trial LFI and a potential benefit of LFI in patients with pre-trial FR. These results corroborate with the primary results and support that there is no need to routinely initiate or continue FR in stable patients with chronic HF.
METHODS: The open-label FRESH-UP study randomized 504 patients with chronic HF to an advice of LFI or FR of 1500 ml/day. Primary outcome was the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS) after 3 months adjusted for baseline. Key secondary outcome was thirst distress. Patient-reported fluid intake was assessed at Week 6. Safety outcomes included death and hospitalizations. For this subanalysis, participants were stratified according to pre-trial fluid management (FR or LFI).
RESULTS: Prior to randomization, 269 (53.4%) patients adhered to FR and 235 (46.6%) adhered to LFI. After 3 month follow-up, KCCQ-OSS was significantly different between groups (P = .035): in patients changing from pre-trial FR to LFI, KCCQ-OSS was 74.7 [95% confidence interval (CI) 71.2-78.3] compared to 70.2 (95% CI 66.3-74.2) in those with the reversed scenario. In the latter group, thirst distress increased the most. Patient-reported fluid intake was significantly higher in patients randomized to LFI when compared to FR (P = .019), regardless of pre-trial FR or LFI (1771 and 1757 ml, vs 1486 and 1464 ml, respectively). Safety outcomes did not differ.
CONCLUSIONS: These analyses add understanding to the effects of fluid intake management in chronic HF and expose a signal of potential harm of FR in patients with pre-trial LFI and a potential benefit of LFI in patients with pre-trial FR. These results corroborate with the primary results and support that there is no need to routinely initiate or continue FR in stable patients with chronic HF.