Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake (FRESH-UP)

Radboud University Medical Center

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Lifestyle advice for liberal fluid intake

Study type: Interventional

Funder types: Other

Identifiers

NCT04551729

75112

Details and patient eligibility

About

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.

Enrollment: 504 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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504 participants in 2 patient groups

Fluid restriction

Active Comparator group

Description:

Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.

Treatment:

Behavioral: Lifestyle advice for liberal fluid intake

Liberal fluid intake

Experimental group

Description:

Patient will receive a lifestyle advice for liberal fluid intake for 3 months.

Treatment:

Behavioral: Lifestyle advice for liberal fluid intake