Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
NCT ID: NCT04551729
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
504 participants
INTERVENTIONAL
2021-04-21
2024-11-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Fluid restriction
Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.
Lifestyle advice for liberal fluid intake
Lifestyle advice for liberal fluid intake for 3 months
Liberal fluid intake
Patient will receive a lifestyle advice for liberal fluid intake for 3 months.
Lifestyle advice for liberal fluid intake
Lifestyle advice for liberal fluid intake for 3 months
Interventions
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Lifestyle advice for liberal fluid intake
Lifestyle advice for liberal fluid intake for 3 months
Eligibility Criteria
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Inclusion Criteria
* Adult (age ≥ 18 years)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Roland van Kimmenade, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Hospital Group Twente
Almelo, , Netherlands
Rijnstate Hospital
Arnhem, , Netherlands
Zuyderland Ziekenhuis
Heerlen, , Netherlands
Dijklander Ziekenhuis
Hoorn, , Netherlands
Maastricht University Medical Centre
Maastricht, , Netherlands
Bernhoven Ziekenhuis
Uden, , Netherlands
Countries
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References
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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.
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 Jun;31(6):2062-2068. doi: 10.1038/s41591-025-03628-4. Epub 2025 Mar 30.
Provided Documents
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Document Type: Study Protocol: Version 2.0 (First approved version)
Document Type: Study Protocol: Version 4.4 (Most recent version)
Document Type: Study Protocol: Summary of Changes V1.0
Document Type: Study Protocol: Summary of Changes V1.0. Appendix
Document Type: Statistical Analysis Plan: Version 1.0
Document Type: Statistical Analysis Plan: Version 2.0
Other Identifiers
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75112
Identifier Type: -
Identifier Source: org_study_id
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