a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
UMCG
RECRUITING
Groningen
Contact Information
Primary
Jozine M. ter Maaten, MD, PhD
j.m.ter.maaten@umcg.nl
+31503616161
Backup
Lara E.E.C. Zonneveld, MD
+31503616161
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 270
Related Therapeutic Areas
Sponsors
Leads: University Medical Center Groningen

This content was sourced from clinicaltrials.gov