Actively Recruiting
A Pragmatic Observational Study of Congestion Profiles in Patients With Acute Heart Failure
Led by University Medical Center Groningen · Updated on 2025-09-10
270
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying acute heart failure, focusing on different types of congestion in patients admitted with this condition. The study aims to understand how common these congestion types are and how they relate to patients' responses to treatment and their health outcomes. This observational, prospective study involves patients who need intravenous loop diuretics and examines various effects of congestion on heart failure progression and recovery. Participants will have several additional assessments beyond usual care. These include ultrasound measures of filling pressures, lung and kidney investigations, liver stiffness tests using Fibroscan, and specialized imaging of the small blood vessels under the tongue. Some participants will join substudies involving skin biopsies to study tissue properties and evaluation of blood proteins related to venous congestion and endothelial function. During the hospital stay, researchers will monitor congestion types from admission until discharge, which typically occurs within 5 to 10 days. They will measure urine sodium output after 24 hours and track rehospitalization or death over six months. Other outcomes include hospital stay length, congestion status at discharge, and changes in heart filling pressures. Participants will undergo multiple scans and tests, and data on therapy response and long-term outcomes will be collected to better understand acute heart failure management.
CONDITIONS
Brief Title
a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to give written informed consent
- Age 65 18 years
- Male or female
- Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion
- Requirement of intravenous loop diuretics
You will not qualify if you...
- Patients with severe kidney dysfunction requiring ultrafiltration or dialysis
- Previous participation in this study
- Inability to follow instructions
- Dyspnoea or oedema primarily due to non-cardiac causes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 to 10 days
Participants are observed during their hospital admission to study congestion profiles and response to therapy in acute heart failure.
Daily assessments during hospital stay
Duration - 6 months
Participants are followed for outcomes including rehospitalization and mortality after discharge.
Follow-up assessments up to 6 months after discharge
Trial Site Locations
Total: 1 location
1
UMCG
Groningen, Netherlands
Actively Recruiting
Research Team
J
Jozine M. ter Maaten, MD, PhD
L
Lara E.E.C. Zonneveld, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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