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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Lifestyle advice for liberal fluid intake
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboud University Medical CenterRecruiting
  • Rijnstate HospitalRecruiting
  • Zuyderland ZiekenhuisRecruiting
  • Maastricht University Medical CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fluid restriction

Liberal fluid intake

Arm Description

Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.

Patient will receive a lifestyle advice for liberal fluid intake for 3 months.

Outcomes

Primary Outcome Measures

Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (scores minimum-maximum 0-100)

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
July 6, 2022
Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04551729
Brief Title
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Acronym
FRESH-UP
Official Title
Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
Maastricht University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
506 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fluid restriction
Arm Type
Active Comparator
Arm Description
Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months.
Arm Title
Liberal fluid intake
Arm Type
Experimental
Arm Description
Patient will receive a lifestyle advice for liberal fluid intake for 3 months.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle advice for liberal fluid intake
Intervention Description
Lifestyle advice for liberal fluid intake for 3 months
Primary Outcome Measure Information:
Title
Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (scores minimum-maximum 0-100)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roland van Kimmenade, MD PhD
Phone
+31-24-3616785
Email
roland.vankimmenade@radboudumc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Frank Gommans, MD PhD
Phone
+31-24-3616785
Email
Frank.gommans@radboudumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland van Kimmenade, MD PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roland RJ van Kimmenade, MD PhD
Phone
+31-24-3616785
Email
roland.vankimmenade@radboudumc.nl
Facility Name
Rijnstate Hospital
City
Arnhem
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ron Pisters, MD PhD
Facility Name
Zuyderland Ziekenhuis
City
Heerlen
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra van Wijk, MD PhD
Facility Name
Maastricht University Medical Centre
City
Maastricht
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans-Peter Brunner-La Rocca, MD Phd

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35705150
Citation
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.
Results Reference
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Fluid Restriction in Heart Failure Versus Liberal Fluid Uptake

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