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

NCT ID: NCT06587854

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2029-12-31

Brief 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

Detailed Description

Objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients.

Study design: Observational, prospective study

Study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.

Main study parameters/endpoints:

To identify distinct congestion phenotypes and study their association with response to therapy and outcomes

Secondary outcomes: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Exploratory outcomes include: length of hospital stay, congestion at discharge and changes in filling pressures over time. Furthermore, as part of the GLYCO-AHF substudy: the expression of glycosaminoglycans and, as part of the PREACH-AHF substudy: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins.

Conditions

Acute Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Jozine ter Maaten

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UMCG

Groningen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Jozine M. ter Maaten, MD, PhD

Role: CONTACT

j.m.ter.maaten@umcg.nl

+31503616161

Lara E.E.C. Zonneveld, MD

Role: CONTACT

+31503616161

Facility Contacts

Lara E.E.C. Zonneveld, MD

Role: primary

l.e.e.c.zonneveld@umcg.nl

+31503616161

Other Identifiers

20486

Identifier Type: -

Identifier Source: org_study_id