Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 504
- Locations
- 8
- Primary Endpoint
- Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The members of the event adjudication committee will be blinded for treatment allocation. Moreover, the statistician who performs the primary analysis will be blinded for treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Fluid restriction
Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.
Intervention: Lifestyle advice for liberal fluid intake (Behavioral)
Liberal fluid intake
Patient will receive a lifestyle advice for liberal fluid intake for 3 months.
Intervention: Lifestyle advice for liberal fluid intake (Behavioral)
Outcomes
Primary Outcomes
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 3 months
KCCQ Overall Summary Score (OSS) (scores minimum-maximum 0-100, higher scores indicate better outcome)
Secondary Outcomes
- Thirst distress(3 months)
- Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)(3 months)
- Quality of life assessed with EQ-5D-5L(3 months)
- Patient reported fluid intake(6 weeks)
- Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)(6 months)