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Liberal or Restricted Fluid Intake in Patients With Heart Failure

Study acronym: FLUID-HF
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Enrollment target: 324 to 326
    • Study title revised
    v4
  2. Notable Primary completion date: Sep 2025 to Dec 2028v3 Show 8 more changesShow less
    • Enrollment target: 250 to 324
    • Study completion date: Sep 2030 to Dec 2028
    • Start date: Jan 23, 2024 to Feb 14, 2024
    • Interventions: Unlimited fluid restrictions (Other) to Free fluid intake (Behavioral)
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints: 4 to 9
    • Study description shortened, about 219 words
    • Collaborators expanded, about 6 words
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2023 to Jan 23, 2024
    • Site details revised
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT05931614
Lead Sponsor Region Stockholm
Collaborators: Capio Sankt Görans Hospital, Ersta Hospital, Sweden
Conditions
(from sponsor)
Heart Failure
Related terms Heart Failure
Enrollment 326 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov