a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure
Recruiting · NCT06587854 · Observational (researchers observe without assigning treatment) · Lead sponsor: University Medical Center Groningen
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
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
Where it is running
1 location listed.
- UMCG - Groningen, Netherlands