Unlimited or Restricted Fluid Intake in Patients with Heart Failure
- Conditions
- Heart Failure
- Interventions
- Other: Unlimited fluid restrictions
- Registration Number
- NCT05931614
- Lead Sponsor
- Region Stockholm
- 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.
- Detailed Description
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 the improvement in medical treatment, we still face challenges in readmission to hospital and in 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 quality of life, physical function, signs and symptoms and readmission to hospital.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 324
- Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
- Physical, cognitive and linguistic ability to carry out all aspects of the study
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Unlimited fluid intake Unlimited fluid restrictions Patients have no restrictions of fluid intake
- Primary Outcome Measures
Name Time Method B-lines 12 weeks The patients will be investigated with lung ultrasound to screen for B-lines (comet tail artifacts) to assess pulmonary congestion
NT-proBNP 12 weeks Specific biomarkers for heart failure (blood test)
- Secondary Outcome Measures
Name Time Method HRQoL 12 weeks Health related quality of life measured with EQ5D
Heart failure symptoms 12 weeks Symptoms of heart failure measured by questionnaires
Thirst distress 12 weeks Self-Care 12 weeks Self-care in chronic illness, measured by a questionnaire
IVC 12 weeks Ultrasound of Inferior Vena Cava (IVC) diameter and respiratory variation.
Pleural effusion 12 weeks Lungultrasound with screening for pleural effusion
Physical Capacity 12 weeks Physical Capacity measured by six minutes walktest
Hospital readmissions 12 weeks Hospital readmissions within three months
Heart failure events 12 weeks Contact with helathcare due to heart failure symtoms, increased use of diuretics with/without admission etc.
Trial Locations
- Locations (1)
Karolinska University Hospital
🇸🇪Stockholm, Sweden