Liberal or Restricted Fluid Intake in Patients With Heart Failure

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Stockholm

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with left ventricual heart failure (HFrEF, HFmEF)

Physical, cognitive and linguistic ability to carry out all aspects of the study

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Free fluid intake

    Behavioral

    Patients are recommended a free fluid intake

Treatment groups

326 Participants
are divided into 2 treatment groups
Group A: Free fluid intakeExperimental treatment 1 intervention
Group B: Restricted fluid intakeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

B-lines

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

Time frame
12 weeks
2

NT-proBNP

Specific biomarkers for heart failure (blood test)

Time frame
12 weeks

Secondary outcomes

1

Heart failure symptoms

Symptoms of heart failure measured by questionnaires

Time frame
12 weeks
2

HRQoL

Health related quality of life measured with EQ5D

Time frame
12 weeks
3

Thirst distress

Time frame
12 weeks
4

Self-Care

Self-care in chronic illness, measured by a questionnaire

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Stockholm

Lead sponsor

Capio Sankt Görans Hospital

Collaborator

Ersta Hospital, Sweden

Collaborator