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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

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.

Secondary outcomes

1

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.

Time frame
24 hours
2

Rehospitalization and/or death after 6 months

Time frame
180 days

Other outcomes

1

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,.

Time frame
Date of discharge, or maximum two days before. Expected to be between 5-10 days after admission.
2

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.

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.
3

Length of stay

Number of days of the index hospitalization

Time frame
Variable, from date of admission untill date of discharge. Expected to be between 5-10 days after admission.
4

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).

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.

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