Karolinska University Hospital
Stockholm, 17176, Sweden
Location status: Recruiting
NCT Number: NCT05931614
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, 17176, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are recommended a free fluid intake
Time frame: 12 weeks
The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
Time frame: 12 weeks
Specific biomarkers for heart failure (blood test)
Time frame: 12 weeks
Symptoms of heart failure measured by questionnaires
Time frame: 12 weeks
Health related quality of life measured with EQ5D
Time frame: 12 weeks
Time frame: 12 weeks
Self-care in chronic illness, measured by a questionnaire
Time frame: 12 weeks
Ultrasound of Inferior Vena Cava (IVC) diameter and respiratory variation.
Time frame: 12 weeks
Lungultrasound with screening for pleural effusion
Time frame: 12 weeks
Physical Capacity measured by six minutes walktest
Time frame: 12 weeks
Hospital readmissions within three months
Time frame: 12 weeks
Contact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc.
Contact information is provided by the study sponsor or research team.
Region Stockholm
Other Gov
Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
Acronym: FLUID-HF
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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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