Actively Recruiting

Age: 18Years +
All Genders
ID06587854

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

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

Long-term Monitoring

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

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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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