About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Adult patients admitted to the hospital with a primary diagnosis of acute heart failure
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Total natriuresis after 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.
Rehospitalization and/or death after 6 months
Other outcomes
Congestion at discharge
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,.
Changes in filling pressures over time
Using either a Swan Ganz catheter (if present as part of standard of care) or echocardiography, intravasculair filling pressures will be measured daily.
Length of stay
Number of days of the index hospitalization
Liver stiffness, as assessed with Fibroscan
Congestion of the liver reflected by liver stifness will be determined after admission and at discharge (with maximum two days before).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.