Clinical trial NCT06587854: a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure
Official title: a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Heart Failure
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients admitted to the hospital with a primary diagnosis of acute heart failure

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.

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

Primary outcomes:
measure: To study the prevalence of distinct congestion phenotypes
timeFrame: 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:
measure: Total natriuresis after 24 hours
timeFrame: 24 hours
measure: Rehospitalization and/or death after 6 months
timeFrame: 180 days
Other outcomes:
measure: Congestion at discharge
timeFrame: Date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
measure: Changes in filling pressures over time
timeFrame: From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
measure: Length of stay
timeFrame: Variable, from date of admission untill date of discharge. Expected to be between 5-10 days after admission.
measure: Liver stiffness, as assessed with Fibroscan
timeFrame: From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
measure: Differences in microvasculature
timeFrame: From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
measure: (Substudy GLYCO-AHF): Differences in glycosaminoglycan network
timeFrame: From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
measure: (Substudy PREACH-AHF): Effects of peripheral venous congestion on plasma proteins
timeFrame: Date of discharge, or maximum two days before.
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