Unlimited or Restricted Fluid Intake in Patients With Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to determine if unlimited fluid intake can improve quality of life and decrease thirst distress in patients with heart failure, without an impact on symptoms, physical capacity, and hospitals readmissions.

Detailed Description
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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 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.

Official Title
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Unlimited or Restricted Fluid Intake in Patients With Heart Failure: a Randomized Controlled Intervention Study

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Unlimited fluid restrictions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with heart failure with reduced ejection fraction (EF <50%) within 3 months hospitalized due to HF deterioration at Karolinska University Hospital at the in-hospital cardiology wards. Ability to provide informed consent. Exclusion Criteria: Reversible cause of HF (thyroid disorders, severe anemia, etc.) Hyponatremia at baseline (sodium < 130 mmol/L) Kidney function measured with eGFR where eGFR of < 30mL/min/1.73m2 at baseline Scheduled cardiac surgery within 3 months Recent (within 3 months) coronary intervention (percutaneous coronary intervention or coronary artery bypass graft surgery) Comorbidity for which fluid restriction is advised Life expectancy < 6 months Ongoing investigation for eligebility of heart transplantation and/or LVAD Pregnancy or planned pregnancy Particiaption in another ongoing clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unlimited fluid intake<br>Patients have no restrictions of fluid intake | Other: Unlimited fluid restrictions<br>* Patients are recommended unlimited fluid intake<br>|
| No Intervention: Restricted fluid intake<br>Patients have restrictions in fluid intake of 1500 ml/day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| B-lines | The patients will be investigated with lung ultrasound to screen for b-lines (comet tail artifacts) to assess pulmonary congestion | 12 weeks | 
| NT-proBNP | Specific biomarkers for heart failure (blood test) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure symptoms | Symptoms of heart failure measured by questionnaires | 12 weeks | 
| HRQoL | Health related quality of life measured with EQ5D | 12 weeks | 
| Physical Capacity | Physical Capacity measured by six minutes walktest | 12 weeks | 
| Hospital readmissions | Hospital readmissions within three months | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Intervention, Thirst distress, Symptoms, Physical capacity, Hospital readmissions, Lung ultrasound, Fluid intake, B-lines, NT-ProBNP, Heart failure, Fluid restriction