Heart Failure
Conditions
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.
Interventions
BEHAVIORALLifestyle advice for liberal fluid intake
Lifestyle advice for liberal fluid intake for 3 months
Sponsors
Maastricht University Medical Center
Radboud University Medical Center
Study design
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
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3 months | KCCQ Overall Summary Score (OSS) (scores minimum-maximum 0-100, higher scores indicate better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thirst distress | 3 months | Thirst Distress Scale for patients with Heart Failure (scores minimum-maximum 8-40, higher scores indicate worse outcome) |
| Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) | 3 months | KCCQ Clinical Summary Score (CSS) and each of the KCCQ domains (scores minimum-maximum 0-100, higher scores indicate better outcome) |
| Quality of life assessed with EQ-5D-5L | 3 months | EQ-5D-5L (First part; scores minimum-maximum 0-1. Second part; (scores minimum-maximum 0-100, higher scores indicate better outcome) |
| Patient reported fluid intake | 6 weeks | Patient reported fluid intake for 1 week in a fluid intake diary |
| Safety (Death, all-cause hospitalisations, iv loop diuretic treatment) | 6 months | Composite of death, hospitalisations and iv loop diuretic treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety (acute kidney injury) | 6 months | Number of occurrences of acute kidney injury (defined as a 50% decline in estimated glomerular filtration rate relative to baseline, or decrease of \>30 ml/min/1.73m2 and to a value below 60 ml/min/1.73m2) |
| Serum biomarkers | 3 months | NT-proBNP |
| Weight | 3 months | Weight |
| Medication | 6 months | Use of concomitant medication (diuretics in particular) |
| Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics) | 6 months | Number of occurrences of: death, all-cause or unplanned HF hospitalisation or the requirement of iv-loop diuretics |
Countries
Netherlands
Outcome results
None listed