Liberal or Restricted Fluid Intake in Patients With Heart Failure

NCT05931614 | Recruiting

• 1 other identifier: K 2023-3124
• Study Type: interventional
• Target: 326
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Heart failure symptoms

  12 weeks

• HRQoL

  12 weeks

• Thirst distress

  12 weeks

• Self-Care

  12 weeks

• IVC

  12 weeks

Study Arms (2)

Free fluid intake

EXPERIMENTAL

Patients have no restrictions of fluid intake

Behavioral: Free fluid intake

Restricted fluid intake

NO INTERVENTION

Patients are recommended a restricted fluid intake of 1500 mL/day

Interventions

Free fluid intake BEHAVIORAL

Patients are recommended a free fluid intake

Free fluid intake

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with left ventricual heart failure (HFrEF, HFmEF)
• Physical, cognitive and linguistic ability to carry out all aspects of the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Capio Sankt Görans Hospital: collaborator
• Ersta Hospital, Sweden: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Carolin Nymark, PhD

  Karolinska Universitetssjukhuset, Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolin Nymark, PhD

CONTACT

+46725955887; carolin.nymark@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Development

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 5, 2023
• Study Start: February 14, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)