Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Heart Failure Clinical Trial

— FRESH-UP  

Official title:

Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04551729
• Other study ID #: 75112
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2022
• Source: Radboud University Medical Center
• Contact: Roland van Kimmenade, MD PhD
• Phone: +31-24-3616785
• Email: roland.vankimmenade[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Lifestyle advice for liberal fluid intake
Lifestyle advice for liberal fluid intake for 3 months

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

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