Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake (NCT04551729) | Clinical Trial Compass
CompletedNot Applicable
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Netherlands504 participantsStarted 2021-04-21
Plain-language summary
Multi-centre open-label 1:1 randomized clinical trial in chronic heart failure patients on the effect of fluid restriction versus liberal fluid intake on quality of life.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of chronic HF with NYHA class II/III according to the prevailing guidelines \> 6 months prior to randomization (1)
* Adult (age ≥ 18 years)
Exclusion Criteria:
* Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
* Hospital admission for HF within 3 months of randomization
* Chronic HF with NYHA class IV
* Hyponatremia at baseline (sodium \<130mmol/l)
* Changes in HF medical therapy in last 14 days prior to randomization
* Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at baseline
* Scheduled cardiac surgery within 3 months of randomization
* Recent (within 3 months) coronary intervention (PCI or CABG) or implantation of pacemaker device
* Comorbidity for which fluid restriction is advised by a different treating physician (e.g. nephrologist)
* Comorbidity with a life expectancy of less than 6 months
* The treating clinician believes that participation in the domain would not be in the best interests of the patient
* Inability to provide informed consent
What they're measuring
1
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)