Fact CheckerSign in

NCT06587854Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
270 (estimated)
First submitted
25 Aug 2024
Start date
1 May 2025
Primary completion date
30 Jun 2028
Lead sponsor
University Medical Center Groningen
NCT number
NCT06587854

What you commit to

  • Study type: Observational
  • Planned participants: 270
  • From 1 May 2025 to the primary completion date, 30 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous participation in this study

Other illness

  • Dyspnoea or oedema primarily due to non-cardiac causes

Other

  • Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis)
  • Inability to follow instructions

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UMCG
Coordinator of this site? Confirm its status
GroningenNetherlandsRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.