Fluid intake options for patients with heart failure
Official title: Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
Run by Region Stockholm · NCT05931614 · Data updated 2026-11-12
This study tests whether allowing heart failure patients to drink as much fluid as they want is better for their health and well-being than limiting their fluid intake.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | February 14, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT05931614 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with heart failure who can physically and cognitively participate in the trial.
✕Probably not a fit
Patients with reversible causes of heart failure or significant comorbidities that require specific fluid management may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of unlimited versus restricted fluid intake in patients diagnosed with heart failure. It aims to evaluate how different fluid intake strategies impact symptoms, quality of life, and physical capacity in these patients. Given the lack of strong evidence supporting fluid restriction as a self-care method, this trial seeks to provide clarity on the best approach for managing fluid intake in heart failure patients. Participants will be monitored for their ability to manage their fluid intake and the resulting effects on their health outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for heart failure patients, enhancing their quality of life and reducing hospital readmissions.
How similar studies have gone: Other studies have indicated the need for more evidence on fluid management in heart failure, suggesting this approach is novel and underexplored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Karolinska University Hospital
Stockholm, Sweden Recruiting
Study contacts
- Principal investigator: Carolin Nymark, PhD — Karolinska Universitetssjukhuset, Heart and Vascular Center
- Study coordinator: Carolin Nymark, PhD
- Email: carolin.nymark@ki.se
- Phone: +46725955887
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.