Clinical trial NCT05931614: Unlimited or Restricted Fluid Intake in Patients with Heart Failure
Official title: Unlimited or Restricted Fluid Intake in Patients with Heart Failure: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Capio Sankt Görans Hospital
name: Ersta Hospital, Sweden
First posted: 2023-07-05
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: B-lines
timeFrame: 12 weeks
measure: NT-proBNP
timeFrame: 12 weeks
Secondary outcomes:
measure: Heart failure symptoms
timeFrame: 12 weeks
measure: HRQoL
timeFrame: 12 weeks
measure: Thirst distress
timeFrame: 12 weeks
measure: Self-Care
timeFrame: 12 weeks
measure: IVC
timeFrame: 12 weeks
measure: Pleural effusion
timeFrame: 12 weeks
measure: Physical Capacity
timeFrame: 12 weeks
measure: Hospital readmissions
timeFrame: 12 weeks
measure: Heart failure events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Universitetssjukhuset, Heart and Vascular Center
name: Carolin Nymark, PhD
role: PRINCIPAL_INVESTIGATOR
References: