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Completed

NCT Number: NCT04551729

Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle advice for liberal fluid intake

Behavioral

Lifestyle advice for liberal fluid intake for 3 months

Primary outcomes

  1. Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 3 months

    KCCQ Overall Summary Score (OSS) (scores minimum-maximum 0-100, higher scores indicate better outcome)

Secondary outcomes

  1. Thirst distress

    Time frame: 3 months

    Thirst Distress Scale for patients with Heart Failure (scores minimum-maximum 8-40, higher scores indicate worse outcome)

  2. Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 3 months

    KCCQ Clinical Summary Score (CSS) and each of the KCCQ domains (scores minimum-maximum 0-100, higher scores indicate better outcome)

  3. Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 3 months

    Proportion of patients with clinically meaningful changes in KCCQ-OSS and KCCQ-CSS (improved: ≥5 points increase; stable: <5 points increase or decrease; declined: ≥5 points decrease)

  4. Quality of life assessed with EQ-5D-5L

    Time frame: 3 months

    EQ-5D-5L (First part; scores minimum-maximum 0-1. Second part; (scores minimum-maximum 0-100, higher scores indicate better outcome)

  5. Patient reported fluid intake

    Time frame: 6 weeks

    Patient reported fluid intake for 1 week in a fluid intake diary

  6. Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)

    Time frame: 6 months

    Composite of death, hospitalisations and iv loop diuretic treatment

Other outcomes

  1. Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics)

    Time frame: 6 months

    Number of occurrences of: death, all-cause or unplanned HF hospitalisation or the requirement of iv-loop diuretics

  2. Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics)

    Time frame: 6 months

    Time to first occurrence of: death, all-cause or unplanned HF hospitalisation or the requirement of iv-loop diuretics

  3. Safety (acute kidney injury)

    Time frame: 6 months

    Number of occurrences of acute kidney injury (defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2)

  4. Safety (acute kidney injury)

    Time frame: 6 months

    Time to first occurrence of acute kidney injury (defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of >30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2)

  5. Serum biomarkers

    Time frame: 3 months

    NT-proBNP

  6. Serum biomarkers

    Time frame: 3 months

    Sodium

  7. Serum biomarkers

    Time frame: 3 months

    Osmolality

  8. Serum biomarkers

    Time frame: 3 months

    Haemoglobin

  9. Serum biomarkers

    Time frame: 3 months

    Haematocrit

  10. Weight

    Time frame: 3 months

    Weight

  11. Medication

    Time frame: 6 months

    Use of concomitant medication (diuretics in particular)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Maastricht University Medical Center

Registry information

Acronym: FRESH-UP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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