NCT04551729Completed
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Source: ClinicalTrials.gov · Last updated 18 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 504 (actual)
- First submitted
- 10 Sept 2020
- Start date
- 21 Apr 2021
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Heart failure
- NCT number
- NCT04551729
What you commit to
- Study type: Interventional
- Participants enrolled: 504
- From 21 Apr 2021 to the primary completion date, 23 Sept 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Changes in HF medical therapy in last 14 days prior to randomization
Other illness
- Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
- Scheduled cardiac surgery within 3 months of randomization
Lab values
- Hyponatremia at baseline (sodium \<130mmol/l)
- Estimated Glomerular Filtration Rate (eGFR) of \< 30ml/min/1.73 m2 at baseline
Other
- Hospital admission for HF within 3 months of randomization
- Chronic HF with NYHA class IV
- 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
Who the study is looking for
- Diagnosis of chronic HF with NYHA class II/III according to the prevailing guidelines \> 6 months prior to randomization (1)
- Adult (age ≥ 18 years)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Group Twente Coordinator of this site? Confirm its status | Almelo | Netherlands | Unknown status |
| Rijnstate Hospital Coordinator of this site? Confirm its status | Arnhem | Netherlands | Unknown status |
| Zuyderland ziekenhuis Coordinator of this site? Confirm its status | Heerlen | Netherlands | Unknown status |
| Dijklander Ziekenhuis Coordinator of this site? Confirm its status | Hoorn | Netherlands | Unknown status |
| Maastricht University Medical Centre Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Unknown status |
| Bernhoven Ziekenhuis Coordinator of this site? Confirm its status | Uden | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.