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NCT Number: NCT05931614

Liberal or Restricted Fluid Intake in Patients With Heart Failure

Heart failure is the most common cause of admission to hospital and is associated with high morbidity and mortality. Treatment options consist of medical- and device treatment and self-care strategies, where fluid restriction has been one of the components in the self-care management of patients with chronic heart failure. The medical treatment has progressed and improved over the years and considerably over the last few years, which has decreased symptoms and improved physical function of these patients. Despite our great success in the medical treatment of heart failure, we still face challenges in hospital readmissions and treatment strategies. It contributes to the increased need of evidence on, if and how, fluid intake and fluid restriction should be used as a self-care method. Fluid restriction as a self-care treatment is still commonly recommended in heart failure management although the scientific clinical evidence is lacking. Fluid restriction is associated with a higher degree of thirst and lower rated quality of life, and there is no consensus on how fluid restriction should be used, no plan for individualized treatment and no agreement on how fluid restriction should be a part of the patient self-care treatment. There is therefore a need for knowledge on how heart failure patients are affected by fluid restriction regarding clincal signs and symptoms of heart failure, quality of life, physical function, readmission to hospital or heart failure events. The primary aim of the study is to investigate whether a free fluid intake is safe compared to a restricted fluid intake, regarding clinical signs of heart failure measured as the presence of B-lines and/or an increase in NT-proBNP. The secondary aim is to clarify whether an unlimited fluid intake can improve quality of life and reduce thirst without affecting heart failure symptoms, physical activity, hospital readmissions and/or heart failure events.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location status: Recruiting

Location contact

Carolin Nymark, PhD

CONTACT

[email protected]

+46725955887

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
  • Physical, cognitive and linguistic ability to carry out all aspects of the study

Exclusion criteria

  • Reversible cause of HF (thyroid disorders, severe anemia, etc.)
  • Hyponatremia at baseline (sodium <130 mmol/L)
  • eGFR at baseline <30mL/min/1.73m2
  • Scheduled cardiac surgery, coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) within 3 months
  • Myocardial infarction within 3 months
  • Comorbidity for which fluid restriction or unlimited fluid intake is advised
  • Life expectancy <6 months

Treatment and study plan

Free fluid intake

Behavioral

Patients are recommended a free fluid intake

Primary outcomes

  1. B-lines

    Time frame: 12 weeks

    The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion

  2. NT-proBNP

    Time frame: 12 weeks

    Specific biomarkers for heart failure (blood test)

Secondary outcomes

  1. Heart failure symptoms

    Time frame: 12 weeks

    Symptoms of heart failure measured by questionnaires

  2. HRQoL

    Time frame: 12 weeks

    Health related quality of life measured with EQ5D

  3. Thirst distress

    Time frame: 12 weeks

  4. Self-Care

    Time frame: 12 weeks

    Self-care in chronic illness, measured by a questionnaire

  5. IVC

    Time frame: 12 weeks

    Ultrasound of Inferior Vena Cava (IVC) diameter and respiratory variation.

  6. Pleural effusion

    Time frame: 12 weeks

    Lungultrasound with screening for pleural effusion

  7. Physical Capacity

    Time frame: 12 weeks

    Physical Capacity measured by six minutes walktest

  8. Hospital readmissions

    Time frame: 12 weeks

    Hospital readmissions within three months

  9. Heart failure events

    Time frame: 12 weeks

    Contact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolin Nymark, PhD

CONTACT

[email protected]

+46725955887

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Capio Sankt Görans Hospital
  • Ersta Hospital, Sweden

Registry information

Official study title

Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial

Acronym: FLUID-HF

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 5, 2023
Registry last updated
Feb 24, 2026

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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