NCT06587854 a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure
| NCT ID | NCT06587854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Center Groningen |
| Condition | Acute Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 270 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 270 participants in total. It began in 2025-05-01 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question\[s\] it aims to answer \[is/are\]: * Primary objective: to study the prevalence of distinct congestion phenotypes * Other objectives (including): * Response to therapy as assessed by * Natriuresis after 24 hours * Rehospitalization and/or deats after 6 months * Length of hospital stay * Congestion at discharge * Changes in filling pressures over time * Relationship between liver stiffness, as assessed with Fibroscan and congestion * Substudy: glycosaminoglycan netword and endothial glycocalyx Participants will undergo several extra study related measurements: * Assessment of filling pressures with ultrasound * Ultrasound investigation of the lungs and kidneys * Fibroscan of the liver * Sidestream darkfield imaging sublingual * As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content. * As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins
Eligibility Criteria
Inclusion Criteria: * Able and willing to give written informed consent * Age ≥ 18 years * Male or female * Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. Diagnosis is based on the criteria in the ESC HF guidelines (1) * Requirement of intravenous loop diuretics Exclusion Criteria: * Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis) * Previous participation in this study * Inability to follow instructions * Dyspnoea or oedema primarily due to non-cardiac causes
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06587854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06587854 currently recruiting?
Yes, NCT06587854 is actively recruiting participants. Contact the research team at j.m.ter.maaten@umcg.nl for enrollment information.
Where is the NCT06587854 trial being conducted?
This trial is being conducted at Groningen, Netherlands.
Who is sponsoring the NCT06587854 clinical trial?
NCT06587854 is sponsored by University Medical Center Groningen. The trial plans to enroll 270 participants.
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