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

NCT06587854 | Recruiting

• 1 other identifier: 20486
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

• To study the prevalence of distinct congestion phenotypes

  Based on the degree of congestion and edema in combination with intravascular pressures, patients will be classified into different phenotypes (high/low intravascular pressures and extensive/minimal edema.

  From date of hospital admission untill the date of discharge (from this admission), with an expected discharge after 5 to 10 days after admission.

Secondary Outcomes (2)

• Total natriuresis after 24 hours

  24 hours

• Rehospitalization and/or death after 6 months

  180 days

Other Outcomes (7)

• Congestion at discharge

  Date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.

• Changes in filling pressures over time

  From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.

• Length of stay

  Variable, from date of admission untill date of discharge. Expected to be between 5-10 days after admission.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients admitted to the hospital with a primary diagnosis of acute heart failure

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood: blood samples from different time points will be collected and stored, for later further analysis Urine: urine samples will be collected and stored, for later further analysis As part of substudy: Skin biopsy: A skin biopsy is collected, with one portion processed for analysis of sodium and water storage, while another portion is used to determine glycosaminoglycan levels

Central Study Contacts

Jozine M. ter Maaten, MD, PhD

CONTACT

+31503616161; j.m.ter.maaten@umcg.nl

Lara E.E.C. Zonneveld, MD

CONTACT

+31503616161

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: September 19, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)