Fluid intake options for patients with heart failure
Liberal or Restricted Fluid Intake in Patients With Heart Failure: a Non-inferiority Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT05931614 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with heart failure who can physically and cognitively participate in the trial.
Not a fit: Patients with reversible causes of heart failure or significant comorbidities that require specific fluid management may not benefit from this study.
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 performed: Other studies have indicated the need for more evidence on fluid management in heart failure, suggesting this approach is novel and underexplored.
Eligibility criteria
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 this trial is running
Stockholm
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.