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Liberal or Restricted Fluid Intake in Patients With Heart Failure

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05931614
Acronym
FLUID-HF
Enrollment
326
Registered
2023-07-05
Start date
2024-02-14
Completion date
2028-12-01
Last updated
2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake, B-lines, NT-ProBNP, Heart failure, Fluid restriction

Brief summary

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.

Interventions

BEHAVIORALFree fluid intake

Patients are recommended a free fluid intake

Sponsors

Region Stockholm
Lead SponsorOTHER_GOV
Capio Sankt Görans Hospital
CollaboratorOTHER
Ersta Hospital, Sweden
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
B-lines12 weeksThe patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP12 weeksSpecific biomarkers for heart failure (blood test)

Secondary

MeasureTime frameDescription
Heart failure symptoms12 weeksSymptoms of heart failure measured by questionnaires
HRQoL12 weeksHealth related quality of life measured with EQ5D
Thirst distress12 weeks
Self-Care12 weeksSelf-care in chronic illness, measured by a questionnaire
IVC12 weeksUltrasound of Inferior Vena Cava (IVC) diameter and respiratory variation.
Pleural effusion12 weeksLungultrasound with screening for pleural effusion
Physical Capacity12 weeksPhysical Capacity measured by six minutes walktest
Hospital readmissions12 weeksHospital readmissions within three months
Heart failure events12 weeksContact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc.

Countries

Sweden

Contacts

CONTACTCarolin Nymark, PhD
carolin.nymark@ki.se+46725955887
PRINCIPAL_INVESTIGATORCarolin Nymark, PhD

Karolinska Universitetssjukhuset, Heart and Vascular Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026