Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study

Job J. Herrmann*, Fabienne Beckers-Wesche, Lisette E. H. J. M. Baltussen, Marjolein H. I. Verdijk, Louise Bellersen, Hans-Peter Brunner-la Rocca, Tiny Jaarsma, Ron Pisters, Sandra Sanders-van Wijk, Laura Rodwell, Niels van Royen, D. H. Frank Gommans, Roland R. J. van Kimmenade

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Aims: It is common practice for clinicians to advise fluid restriction in patients with heart failure (HF), but data from clinical trials are lacking. Moreover, fluid restriction is associated with thirst distress and may adversely impact quality of life (QoL). To address this gap in evidence, the Fluid REStriction in Heart failure vs liberal fluid UPtake (FRESH-UP) study was initiated. Methods: The FRESH-UP study is a randomized, controlled, open-label, multicenter trial to investigate the effects of a 3-month period of liberal fluid intake vs fluid restriction (1500 mL/day) on QoL in outpatients with chronic HF (New York Heart Association Classes II—III). The primary aim is to assess the effect on QoL after 3 months using the Overall Summary Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ). Thirst distress, as assessed by the Thirst Distress Scale for patients with HF, KCCQ Clinical Summary Score, each of the KCCQ domains and clinically meaningful changes in these scores, the EQ-5D-5L, patient-reported fluid intake and safety (ie, death, HF hospitalizations) are secondary outcomes. The FRESH-UP study is registered at ClinicalTrials.gov (NCT04551729). Conclusion: The results of the FRESH-UP study will add substantially to the level of evidence concerning fluid management in chronic HF and may impact the QoL of these patients.
Original languageEnglish
Pages (from-to)1522-1530
Number of pages9
JournalJournal of Cardiac Failure
Issue number10
Early online date2022
Publication statusPublished - Oct 2022
Externally publishedYes

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