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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Lifestyle advice for liberal fluid intake

• Study Type: Interventional
• Enrollment (Anticipated): 506
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roland van Kimmenade, MD PhD; Phone Number: +31-24-3616785; Email: roland.vankimmenade@radboudumc.nl
• Study Contact Backup: Name: Frank Gommans, MD PhD; Phone Number: +31-24-3616785; Email: Frank.gommans@radboudumc.nl

Study Locations

• Netherlands
  • Arnhem, Netherlands
    • Recruiting
    • Rijnstate Hospital
    • Contact: Ron Pisters, MD PhD
  • Heerlen, Netherlands
    • Recruiting
    • Zuyderland Ziekenhuis
    • Contact: Sandra van Wijk, MD PhD
  • Maastricht, Netherlands
    • Recruiting
    • Maastricht University Medical Centre
    • Contact: Hans-Peter Brunner-La Rocca, MD Phd
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Recruiting
      • Radboud University Medical Center
      • Contact: Roland RJ van Kimmenade, MD PhD; Phone Number: +31-24-3616785; Email: roland.vankimmenade@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluid restriction; Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.	Behavioral: Lifestyle advice for liberal fluid intake; Lifestyle advice for liberal fluid intake for 3 months
Experimental: Liberal fluid intake; Patient will receive a lifestyle advice for liberal fluid intake for 3 months.	Behavioral: Lifestyle advice for liberal fluid intake; Lifestyle advice for liberal fluid intake for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (scores minimum-maximum 0-100)	3 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Maastricht University Medical Center
• Investigators: Principal Investigator: Roland van Kimmenade, MD PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• Herrmann JJ, Beckers-Wesche F, Baltussen LEHJM, Verdijk MHI, Bellersen L, Brunner-la Rocca HP, Jaarsma T, Pisters R, Sanders-van Wijk S, Rodwell L, Van Royen N, Gommans DHF, Van Kimmenade RRJ. Fluid REStriction in Heart Failure vs Liberal Fluid UPtake: Rationale and Design of the Randomized FRESH-UP Study. J Card Fail. 2022 Oct;28(10):1522-1530. doi: 10.1016/j.cardfail.2022.05.015. Epub 2022 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 75112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Other investigators can submit a proposal to the steering committee for the sharing of data.

This proposal will be discussed in the steering committee.

• IPD Sharing Time Frame: Weeks
• IPD Sharing Access Criteria: These will be determined by the steering committee.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No