A PRagmatic Observational Study of Congestion ProFILes in PatiEnts with Acute Heart Failure

Not yet recruiting

• Conditions: Acute Heart Failure

• Registration Number: NCT06587854
• Lead Sponsor: University Medical Center Groningen

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

* Natriureis 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: 260 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: natriuresis after 48 and 72 hours, 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.

Study Timeline

• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-09-04
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-17
• Study Start: 2025-01-01
• Primary Completion: 2028-06-30
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 260

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

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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

Additional Exclusion Criteria, only applicable for substudy PREACH-AHF:

• Clinical congestion score >1 at discharge.
• Pulmonary embolism within 1 month before admission and pulmonary hypertension not caused by left ventricle dysfunction.
• Acute infection.
• Active malignancy.
• Prior venous thromboembolism.
• Systolic blood pressure <90 mmHg at discharge.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the prevalence of distinct congestion phenotypes	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 Outcome Measures

Name	Time	Method
Total natriuresis after 24 hours	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	180 days