Heart Failure Clinical Trial
— FRESH-UPOfficial title:
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
NCT number | NCT04551729 |
Other study ID # | 75112 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2021 |
Est. completion date | December 1, 2024 |
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.
Status | Recruiting |
Enrollment | 506 |
Est. completion date | December 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | |
Netherlands | Zuyderland Ziekenhuis | Heerlen | |
Netherlands | Maastricht University Medical Centre | Maastricht | |
Netherlands | Radboud University Medical Center | Nijmegen | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Maastricht University Medical Center |
Netherlands,
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, Royen NV, Gommans DHF, van Kimmenade RRJ. Fluid REStriction in Heart failure versus liberal fluid UPtake: Rationale and design of the randomised FRESH-UP study. J Card Fail. 2022 Jun 12. pii: S1071-9164(22)00544-9. doi: 10.1016/j.cardfail.2022.05.015. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (scores minimum-maximum 0-100) | 3 months |
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