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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
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:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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,. | Date of discharge, or maximum two days before. Expected to be between 5-10 days after admission. |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients admitted to the hospital with a primary diagnosis of acute heart failure
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jozine M. ter Maaten, MD, PhD | Contact | +31503616161 | j.m.ter.maaten@umcg.nl | |
| Lara E.E.C. Zonneveld, MD | Contact | +31503616161 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCG | Recruiting | Groningen | Netherlands |
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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
| Rehospitalization and/or death after 6 months |
| 180 days |
| 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. | 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 | Number of days of the index hospitalization | Variable, from date of admission untill date of discharge. Expected to be between 5-10 days after admission. |
| 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). | From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission. |
| Differences in microvasculature | 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. | From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission. |
| (Substudy GLYCO-AHF): Differences in glycosaminoglycan network | 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). | From date of hospital admission untill the date of discharge, or maximum two days before. Expected to be between 5-10 days after admission. |
| (Substudy PREACH-AHF): Effects of peripheral venous congestion on plasma proteins | 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. | Date of discharge, or maximum two days before. |