Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Lifestyle advice for liberal fluid intake

• Registration Number: NCT04551729
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-16
• Study Start: 2021-04-21
• Primary Completion: 2024-09-23
• Study Completion: 2024-11-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

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)

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Exclusion Criteria

• Reversible cause of HF (thyroid disorders, severe anemia, vitamin deficiencies)
• Hopital 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liberal fluid intake	Lifestyle advice for liberal fluid intake	Patient will receive a lifestyle advice for liberal fluid intake for 3 months.
Fluid restriction	Lifestyle advice for liberal fluid intake	Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ)	3 months	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)
Safety (Death, all-cause hospitalisations, iv loop diuretic treatment)	6 months	Composite of death, hospitalisations and iv loop diuretic treatment

Trial Locations

Locations (8)

Hospital Group Twente; 🇳🇱 Almelo, Netherlands

Radboud University Medical Center; 🇳🇱 Nijmegen, Gelderland, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Zuyderland Ziekenhuis; 🇳🇱 Heerlen, Netherlands

Dijklander Ziekenhuis; 🇳🇱 Hoorn, Netherlands

Maastricht University Medical Centre; 🇳🇱 Maastricht, Netherlands

Bernhoven Ziekenhuis; 🇳🇱 Uden, Netherlands