Fluid REStriction in Heart failure versus liberal fluid UPtake: the FRESH-UP study

Phase 3

Recruiting

Conditions: Heart failure
chronic heart failure
10019280

Registration Number: NL-OMON52269

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 506

Inclusion Criteria

• Diagnosis of chronic heart failure according to the prevailing guidelines > 6
months prior to randomization
• 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
• Hyponatremia at baseline (sodium <130mmol/l)
• Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 at baseline
• Changes in HF medical therapy in last 14 days prior to randomization
• Scheduled cardiac surgery within 3 months of randomization
• Comorbidity for which fluid restriction is advised by a different treating
physician (e.g. nephrologist)
• Inability to provide informed consent

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters are QoL at 3 months after randomization, as assessed<br /><br>with the Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary and other study parameters are thirst distress using a validated<br /><br>thirst distress scale, QoL as assessed with the KCCQ Clinical Summary Score and<br /><br>each of the separate domains, QoL as assessed with a visual analogue scale<br /><br>(EQ-5D-5L), serum biomarkers (NT-proBNP, sodium, osmolality); and the<br /><br>occurrence of adverse events such as death, hospitalisations and need for<br /><br>iv-loop diuretics during the 6-month follow-up.</p><br>