Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake (FRESH-UP)

  • End date
    Dec 1, 2024
  • participants needed
  • sponsor
    Radboud University Medical Center
Updated on 4 October 2022
heart failure
chronic heart failure


Multi-centre open-label 1:1 randomized clinical trial in chronic heart failure patients on the effect of fluid restriction versus liberal fluid intake on quality of life.

Condition Heart Failure
Treatment Lifestyle advice for liberal fluid intake
Clinical Study IdentifierNCT04551729
SponsorRadboud University Medical Center
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Diagnosis of chronic HF with NYHA class II/III according to the prevailing guidelines > 6 months prior to randomization (1)
Adult (age ≥ 18 years)

Exclusion Criteria

Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
Hopital admission for HF within 3 months of randomization
Chronic HF with NYHA class IV
Hyponatremia at baseline (sodium <130mmol/l)
Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at baseline
Changes in HF medical therapy in last 14 days prior to randomization
Scheduled cardiac surgery within 3 months of randomization
Recent (within 3 months) coronary intervention (PCI or CABG) or implantation of pacemaker device
Comorbidity for which fluid restriction is advised by a different treating physician (e.g. nephrologist)
Comorbidity with a life expectancy of less than 6 months
The treating clinician believes that participation in the domain would not be in the best interests of the patient
Inability to provide informed consent
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