Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Radboud University Medical Center504 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

504

Conditions

Heart Failure

Interventions

Lifestyle advice for liberal fluid intakeBEHAVIORAL

Lifestyle advice for liberal fluid intake for 3 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Hospital Group Twente

Almelo, Netherlands

Rijnstate Hospital

Arnhem, Netherlands

Outcomes

Primary Outcomes

Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

KCCQ Overall Summary Score (OSS) (scores minimum-maximum 0-100, higher scores indicate better outcome)

Time frame: 3 months

Secondary Outcomes

Thirst distress

Thirst Distress Scale for patients with Heart Failure (scores minimum-maximum 8-40, higher scores indicate worse outcome)

Time frame: 3 months

Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

KCCQ Clinical Summary Score (CSS) and each of the KCCQ domains (scores minimum-maximum 0-100, higher scores indicate better outcome)

Time frame: 3 months

Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Proportion of patients with clinically meaningful changes in KCCQ-OSS and KCCQ-CSS (improved: ≥5 points increase; stable: \<5 points increase or decrease; declined: ≥5 points decrease)

Time frame: 3 months

Quality of life assessed with EQ-5D-5L

EQ-5D-5L (First part; scores minimum-maximum 0-1. Second part; (scores minimum-maximum 0-100, higher scores indicate better outcome)

Time frame: 3 months

Patient reported fluid intake

Patient reported fluid intake for 1 week in a fluid intake diary

Time frame: 6 weeks

Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)

Composite of death, hospitalisations and iv loop diuretic treatment

Data from ClinicalTrials.gov

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