Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587854
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-25
Brief Title:
A PRagmatic Observational Study of Congestion ProFILes in PatiEnts with Acute Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A PRagmatic Observational Study of Congestion ProFILes in PatiEnts with Acute Heart
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROFILE-AHF
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 questions it aims to answer isare
Primary objective to study the prevalence of distinct congestion phenotypes
Other objectives including
Response to therapy as assessed by
Natriureis after 24 hours
Rehospitalization andor 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
Primary objective to study the prevalence of distinct congestion phenotypes
Other objectives including
Response to therapy as assessed by
Natriureis after 24 hours
Rehospitalization andor 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 parametersendpoints
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 design Observational prospective study
Study population 260 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics
Main study parametersendpoints
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None