Back to resultsAcute Heart Failure - COngestion Repeated Evaluation (AHF-CORE) (AHF-CORE)
Primary Purpose
Acute Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical examination centered on congestion
Cardio-pulmonary and peritoneal ultrasound
Blood sample retrieved for biological assessment and biobanking
Telephone interview
Urinary sample retrieved for biological assessment and biobanking
jugular and renal ultrasound (optional)
Sponsored by
About this trial
This is an interventional other trial for Acute Heart Failure focused on measuring Acute Heart Failure, Congestion, Ultrasound
Eligibility Criteria
Inclusion Criteria:
- Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital
- Patients over 18 years old
- Person affiliated to or beneficiary of a social security plan
- Person informed about study organization and having signed the informed consent
Exclusion Criteria:
- Comorbidity for which life expectancy is ≤ 3 months
- Diagnosis of heart failure made less than 3 months prior to inclusion
- Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation)
- Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline
- History of pulmonary lobectomy or pneumonectomy
- Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis
- Suspected cardiac amylose or proven cardiac amylose
- Woman of childbearing age without effective contraception
- Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
- Persons deprived of liberty for judicial or administrative decision
- Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
Sites / Locations
- CHR Metz-Thionville - Hôpital de MercyRecruiting
- CHRU Nancy Hôpitaux de BraboisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients hospitalized for acute heart failure
Arm Description
One arm study. Patients hospitalized for acute heart failure will undergo the following evaluations: Clinical examination centered on congestion Cardiopulmonary and peritoneal ultrasound Blood sample retrieved for biological assessment and biobanking Telephone interview
Outcomes
Primary Outcome Measures
Rate of all-cause death
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 2 and 3)
Rate of rehospitalization for acute heart failure
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 1 and 3)
Rate of day-hospital or at-home IV diuretics injection for acute HF
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 1 and 2)
Secondary Outcome Measures
Clinical congestion markers as assessed with the Ambrosy Score
Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge
Clinical congestion markers as assessed with the ASCEND score
Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge
Natriuretic peptides
Natriuretic peptides at admission and at final discharge
Estimated plasma volume
Estimated plasma volume at admission and at final discharge
Ultrasound congestion markers
B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion
Residual congestion
as defined as an Ambrosy score 3 or more and/or B-lines score 30 or more and/or an IVC>21 and IVC collapse with sniff <50%
NYHA class
NYHA class (1, 2, 3, 4)
Rate of day-hospital for Intravenous diuretics administration for acute HF
To identify the markers of congestion (clinical, biological, and ultrasonographic), at the end of hospitalization for ICA most strongly associated with the risk of intravenous administration of diuretics in day-hospital for ICA at 3,12, and 24 months after hospital discharge.
Rate of all-cause death
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 12 and 13)
Rate of hospitalization for acute heart failure
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 13)
Rate of day-hospital or in-home IV diuretics injection for acute HF
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 12)
Full Information
NCT ID
NCT03327532
First Posted
September 6, 2017
Last Updated
August 30, 2023
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03327532
Brief Title
Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
Acronym
AHF-CORE
Official Title
Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
February 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The AHF-CORE study is a prospective, non-randomized, multicenter regional study.
The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
Secondary objectives are:
Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure.
Assess the correlation between changes in congestion markers between the beginning and end of hospitalization.
Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization.
Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.
Identify the association of ultrasound and biologic congestion markers assessed at admission and final discharge with NYHA class at 3 months after hospital discharge
Detailed Description
Congestion (clinical, biological and ultrasound evaluation) will be quantified at inclusion within 72 hours of admission and before hospital discharge.
Follow-up at 3 months of hospital discharge will be performed through telephone interviews. Vital status and rehospitalization status will be collected.
Throughout the study, patients will continue to be treated according to usual routine care, regardless of their level of congestion. There will be no modification of treatment according to the congestion data acquired within the setting of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Acute Heart Failure, Congestion, Ultrasound
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients hospitalized for acute heart failure
Arm Type
Experimental
Arm Description
One arm study.
Patients hospitalized for acute heart failure will undergo the following evaluations:
Clinical examination centered on congestion
Cardiopulmonary and peritoneal ultrasound
Blood sample retrieved for biological assessment and biobanking
Telephone interview
Intervention Type
Procedure
Intervention Name(s)
Clinical examination centered on congestion
Intervention Description
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
Intervention Type
Procedure
Intervention Name(s)
Cardio-pulmonary and peritoneal ultrasound
Intervention Description
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
Intervention Type
Biological
Intervention Name(s)
Blood sample retrieved for biological assessment and biobanking
Intervention Description
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
Intervention Type
Other
Intervention Name(s)
Telephone interview
Intervention Description
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
Intervention Type
Biological
Intervention Name(s)
Urinary sample retrieved for biological assessment and biobanking
Intervention Description
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
Intervention Type
Procedure
Intervention Name(s)
jugular and renal ultrasound (optional)
Intervention Description
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital
Primary Outcome Measure Information:
Title
Rate of all-cause death
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 2 and 3)
Time Frame
at 3 months after hospital discharge
Title
Rate of rehospitalization for acute heart failure
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 1 and 3)
Time Frame
at 3 months after hospital discharge
Title
Rate of day-hospital or at-home IV diuretics injection for acute HF
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following the day hospitalization (with outcome 1 and 2)
Time Frame
at 3 months after hospital discharge
Secondary Outcome Measure Information:
Title
Clinical congestion markers as assessed with the Ambrosy Score
Description
Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge
Time Frame
at admission and at final discharge (an average of 10 days after admission)
Title
Clinical congestion markers as assessed with the ASCEND score
Description
Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge
Time Frame
at admission and at final discharge (an average of 10 days after admission)
Title
Natriuretic peptides
Description
Natriuretic peptides at admission and at final discharge
Time Frame
at admission and at final discharge (an average of 10 days after admission)
Title
Estimated plasma volume
Description
Estimated plasma volume at admission and at final discharge
Time Frame
at admission and at final discharge (an average of 10 days after admission)
Title
Ultrasound congestion markers
Description
B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion
Time Frame
at admission and at final discharge (an average of 10 days after admission)
Title
Residual congestion
Description
as defined as an Ambrosy score 3 or more and/or B-lines score 30 or more and/or an IVC>21 and IVC collapse with sniff <50%
Time Frame
at final discharge (an average of 10 days after admission)
Title
NYHA class
Description
NYHA class (1, 2, 3, 4)
Time Frame
3 months after hospital discharge
Title
Rate of day-hospital for Intravenous diuretics administration for acute HF
Description
To identify the markers of congestion (clinical, biological, and ultrasonographic), at the end of hospitalization for ICA most strongly associated with the risk of intravenous administration of diuretics in day-hospital for ICA at 3,12, and 24 months after hospital discharge.
Time Frame
3, 12 and 24 months after hospitalization
Title
Rate of all-cause death
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 12 and 13)
Time Frame
12 and 24 months after hospitalization
Title
Rate of hospitalization for acute heart failure
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 13)
Time Frame
12 and 24 months after hospitalization
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
composite endpoint: rate of all-cause death, hospitalization for acute heart failure or day-hospital IV diuretics injection for acute HF during 24 months following day hospitalization (with outcome 11 and 12)
Time Frame
12 and 24 months after hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital
Patients over 18 years old
Person affiliated to or beneficiary of a social security plan
Person informed about study organization and having signed the informed consent
Exclusion Criteria:
Comorbidity for which life expectancy is ≤ 3 months
Diagnosis of heart failure made less than 3 months prior to inclusion
Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation)
Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate <15 ml / min / m2 at baseline
History of pulmonary lobectomy or pneumonectomy
Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis
Suspected cardiac amylose or proven cardiac amylose
Woman of childbearing age without effective contraception
Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection.
Persons deprived of liberty for judicial or administrative decision
Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GIRERD, MD,PhD
Phone
+ 33 3 83 15 74 96
Ext
+ 33 3
Email
n.girerd@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD,PhD
Organizational Affiliation
Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Metz-Thionville - Hôpital de Mercy
City
Metz
State/Province
Lorraine
ZIP/Postal Code
57000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noura ZANNAD, MD
Facility Name
CHRU Nancy Hôpitaux de Brabois
City
Vandœuvre-lès-Nancy
State/Province
Lorraine
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
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