Clinical trial NCT04551729: Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Official title: Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2020-09-16
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)
* Hospital admission for HF within 3 months of randomization
* Chronic HF with NYHA class IV
* Hyponatremia at baseline (sodium \<130mmol/l)
* Changes in HF medical therapy in last 14 days prior to randomization
* Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at baseline
* 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

Primary outcomes:
measure: Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 3 months
Secondary outcomes:
measure: Thirst distress
timeFrame: 3 months
measure: Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 3 months
measure: Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 3 months
measure: Quality of life assessed with EQ-5D-5L
timeFrame: 3 months
measure: Patient reported fluid intake
timeFrame: 6 weeks
measure: Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)
timeFrame: 6 months
Other outcomes:
measure: Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics)
timeFrame: 6 months
measure: Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics)
timeFrame: 6 months
measure: Safety (acute kidney injury)
timeFrame: 6 months
measure: Safety (acute kidney injury)
timeFrame: 6 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Serum biomarkers
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: Medication
timeFrame: 6 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
city: Almelo
country: Netherlands
facility: Hospital Group Twente
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Ziekenhuis
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Uden
country: Netherlands
facility: Bernhoven Ziekenhuis
Study officials:
affiliation: Radboud University Medical Center
name: Roland van Kimmenade, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrmann JJ, Beckers-Wesche F, Baltussen LEHJM, Verdijk MHI, Bellersen L, Brunner-la Rocca HP, Jaarsma T, Pisters R, Sanders-van Wijk S, Rodwell L, Van Royen N, Gommans DHF, Van Kimmenade RRJ. Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study. J Card Fail. 2022 Oct;28(10):1522-1530. doi: 10.1016/j.cardfail.2022.05.015. Epub 2022 Jun 13.
citation: Herrmann JJ, Brunner-La Rocca HP, Baltussen LEHJM, Beckers-Wesche F, Bekkers SCAM, Bellersen L, van Eck JWM, Hassing HC, Jaarsma T, Linssen GCM, Pisters R, Sanders-van Wijk S, Verdijk MHI, Handoko ML, van der Meer P, Verbrugge FH, Januzzi JL Jr, Bayes-Genis A, Nieuwlaat R, Rodwell L, Gommans DHF, van Kimmenade RRJ. Liberal fluid intake versus fluid restriction in chronic heart failure: a randomized clinical trial. Nat Med. 2025 Mar 30. doi: 10.1038/s41591-025-03628-4. Online ahead of print.