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NCT Number: NCT06587854

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

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

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Key information

Conditions

Acute Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To study the prevalence of distinct congestion phenotypes

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

    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.

Secondary outcomes

  1. Total natriuresis after 24 hours

    Time frame: 24 hours

    To assess this, urine is collected for 24 hours after the first administration of diuretics according to the hospital protocol and natriuresis is calculated as the total amount of diuresis (L) multiplied by the urinary sodium concentration (mmol/L).with natriuresis as the primary outcome measure.

  2. Rehospitalization and/or death after 6 months

    Time frame: 180 days

Other outcomes

  1. Congestion at discharge

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

    Congestion at discharge will be assessed by several measures; clinical symptoms (e.g. orthopnoea, dyspnoea), physical examination (e.g. oedema, rales, jugular venous pressure), ultrasound examination (lungs, heart, inferior vena cava,.

  2. Changes in filling pressures over time

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

    Using either a Swan Ganz catheter (if present as part of standard of care) or echocardiography, intravasculair filling pressures will be measured daily.

  3. Length of stay

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

    Number of days of the index hospitalization

  4. Liver stiffness, as assessed with Fibroscan

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

    Congestion of the liver reflected by liver stifness will be determined after admission and at discharge (with maximum two days before).

  5. Differences in microvasculature

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

    Subligual sidestream darkfield imaging will be performed at day 1 or 2 and will be repeated at discharge (or maximum two days before). This technique allows for a detailed observation of capillary blood flow, capillary density and glycocalyx integrity. Comparing the microvasculature between the different congestion phenotype groups, as well as studying changes in the microvasculature from admission to discharge will provide novel information with regards to the microvasculature in AHF patients.

  6. (Substudy GLYCO-AHF): Differences in glycosaminoglycan network

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

    A skin biopsy will be performed at day 1 or 2. At discharge, or maximum two days before, patients will receive a second skin biopsy. With the biopsy the glycosaminoglycan network and glygocalyx can be determined. Cryosections will be stained using available antibodies for glycosaminoclycans, whereafter their immunochemical expression will be quantified. The expression will be compared between both the different patient groups (based on phenotype) as well as between the two biopsies (at admission and at discharge).

  7. (Substudy PREACH-AHF): Effects of peripheral venous congestion on plasma proteins

    Time frame: Date of discharge, or maximum two days before.

    To study the effect of peripheral venous congestion and endothelial dysfunction on plasma proteins, blood samples will be taken via an intravenous line before and after inflating a pressure cuff, while a pressure transducer measures the peripheral venous pressure. Patients will also undergo a reactive hyperaemia index measurement to investigate the link between plasma proteins and endothelial dysfunction. These measurements will be performed at discharge or a maximum of 2 days before.

Study contacts

Contact information is provided by the study sponsor or research team.

Jozine M. ter Maaten, MD, PhD

CONTACT

[email protected]

+31503616161

Lara E.E.C. Zonneveld, MD

CONTACT

+31503616161

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: PROFILE-AHF

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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