TY - JOUR
T1 - Fluid REStriction in Heart Failure vs Liberal Fluid UPtake
T2 - Rationale and Design of the Randomized FRESH-UP Study
AU - Herrmann, Job J
AU - Beckers-Wesche, Fabienne
AU - Baltussen, Lisette E H J M
AU - Verdijk, Marjolein H I
AU - Bellersen, Louise
AU - Brunner-la Rocca, Hans-Peter
AU - Jaarsma, Tiny
AU - Pisters, Ron
AU - Sanders-van Wijk, Sandra
AU - Rodwell, Laura
AU - Van Royen, Niels
AU - Gommans, D H Frank
AU - Van Kimmenade, Roland R J
N1 - Funding Information:
This work was supported by crowdfunding in collaboration with the Dutch Heart Foundation [2019T100] and by the joint fund of Radboud University Medical Centre in Nijmegen and Maastricht University Medical Centre [R0005106].
Publisher Copyright:
© 2022 The Author(s)
PY - 2022/10
Y1 - 2022/10
N2 - 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.
AB - 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.
KW - Chronic heart failure
KW - Fluid restriction
KW - Liberal fluid intake
KW - Quality of life
UR - https://www.scopus.com/pages/publications/85133734386
U2 - 10.1016/j.cardfail.2022.05.015
DO - 10.1016/j.cardfail.2022.05.015
M3 - Article
C2 - 35705150
SN - 1071-9164
VL - 28
SP - 1522
EP - 1530
JO - Journal of Cardiac Failure
JF - Journal of Cardiac Failure
IS - 10
ER -