Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Last updated: January 29, 2025
Sponsor: Radboud University Medical Center
Overall Status: Completed

Phase

N/A

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

Lifestyle advice for liberal fluid intake

Clinical Study ID

NCT04551729
75112
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Diagnosis of chronic HF with NYHA class II/III according to the prevailingguidelines > 6 months prior to randomization (1)

  • Adult (age ≥ 18 years)

Exclusion

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 ofpacemaker 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 thebest interests of the patient

  • Inability to provide informed consent

Study Design

Total Participants: 504
Treatment Group(s): 1
Primary Treatment: Lifestyle advice for liberal fluid intake
Phase:
Study Start date:
April 21, 2021
Estimated Completion Date:
November 28, 2024

Connect with a study center

  • Radboud University Medical Center

    Nijmegen, Gelderland 6525GA
    Netherlands

    Site Not Available

  • Hospital Group Twente

    Almelo,
    Netherlands

    Site Not Available

  • Rijnstate Hospital

    Arnhem,
    Netherlands

    Site Not Available

  • Jeroen Bosch Ziekenhuis

    Den Bosch,
    Netherlands

    Site Not Available

  • Zuyderland Ziekenhuis

    Heerlen,
    Netherlands

    Site Not Available

  • Dijklander Ziekenhuis

    Hoorn,
    Netherlands

    Site Not Available

  • Maastricht University Medical Centre

    Maastricht,
    Netherlands

    Site Not Available

  • Bernhoven Ziekenhuis

    Uden,
    Netherlands

    Site Not Available

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