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| Name | Class |
|---|---|
| Maastricht University Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluid restriction | Active Comparator | Patient will receive a lifestyle advice to adhere to fluid restriction of 1500cc/day for 3 months. |
|
| Liberal fluid intake | Experimental | Patient will receive a lifestyle advice for liberal fluid intake for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle advice for liberal fluid intake | Behavioral | Lifestyle advice for liberal fluid intake for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Thirst distress | Thirst Distress Scale for patients with Heart Failure (scores minimum-maximum 8-40, higher scores indicate worse outcome) | 3 months |
| Quality of life assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics) | Number of occurrences of: death, all-cause or unplanned HF hospitalisation or the requirement of iv-loop diuretics | 6 months |
| Safety (death, all-cause or unplanned HF hospitalisation, the requirement of iv-loop diuretics) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roland van Kimmenade, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud University Medical Center | Nijmegen | Gelderland | 6525GA | Netherlands | ||
| Jeroen Bosch Ziekenhuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35705150 | Background | 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. | |
| 40159556 |
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Other investigators can submit a proposal to the steering committee for the sharing of data.
This proposal will be discussed in the steering committee.
Weeks
These will be determined by the steering committee.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 2.0 (First approved version) | Nov 30, 2020 | Jun 6, 2024 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Version 4.4 (Most recent version) | May 15, 2024 | Jun 6, 2024 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Summary of Changes V1.0 | Jun 5, 2024 | Jun 6, 2024 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Summary of Changes V1.0. Appendix | Jun 5, 2024 | Jun 6, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Version 1.0 | Sep 1, 2023 | Jun 12, 2024 | SAP_004.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Version 2.0 | Apr 14, 2024 | Jun 12, 2024 | SAP_005.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
KCCQ Clinical Summary Score (CSS) and each of the KCCQ domains (scores minimum-maximum 0-100, higher scores indicate better outcome)
| 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) | 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) | 3 months |
| Patient reported fluid intake | Patient reported fluid intake for 1 week in a fluid intake diary | 6 weeks |
| Safety (Death, all-cause hospitalisations, iv loop diuretic treatment) | Composite of death, hospitalisations and iv loop diuretic treatment | 6 months |
Time to first occurrence of: death, all-cause or unplanned HF hospitalisation or the requirement of iv-loop diuretics |
| 6 months |
| Safety (acute kidney injury) | 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) | 6 months |
| Safety (acute kidney injury) | Time to first occurrence 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) | 6 months |
| Serum biomarkers | NT-proBNP | 3 months |
| Serum biomarkers | Sodium | 3 months |
| Serum biomarkers | Osmolality | 3 months |
| Serum biomarkers | Haemoglobin | 3 months |
| Serum biomarkers | Haematocrit | 3 months |
| Weight | Weight | 3 months |
| Medication | Use of concomitant medication (diuretics in particular) | 6 months |
| 's-Hertogenbosch |
| Netherlands |
| Hospital Group Twente | Almelo | Netherlands |
| Rijnstate Hospital | Arnhem | Netherlands |
| Zuyderland Ziekenhuis | Heerlen | Netherlands |
| Dijklander Ziekenhuis | Hoorn | Netherlands |
| Maastricht University Medical Centre | Maastricht | Netherlands |
| Bernhoven Ziekenhuis | Uden | Netherlands |
| Result |
| Herrmann JJ, Brunner-La Rocca HP, Baltussen LEHJM, Beckers-Wesche F, Bekkers SCAM, Bellersen L, van Eck JWM, Hassing HC, Jaarsma T, Linssen GCM, Pisters R, Sanders-van Wijk S, Verdijk MHI, Handoko ML, van der Meer P, Verbrugge FH, Januzzi JL Jr, Bayes-Genis A, Nieuwlaat R, Rodwell L, Gommans DHF, van Kimmenade RRJ. Liberal fluid intake versus fluid restriction in chronic heart failure: a randomized clinical trial. Nat Med. 2025 Jun;31(6):2062-2068. doi: 10.1038/s41591-025-03628-4. Epub 2025 Mar 30. |