Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)

Acute Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03327532
• Other study ID #: 2017-A01455-48
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: February 2026

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Nicolas GIRERD, MD,PhD
• Phone: + 33 3 83 15 74 96
• Email: n.girerd[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2026
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Procedure:
• Clinical examination centered on congestion
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
• Cardio-pulmonary and peritoneal ultrasound
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital

Biological:
• Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital

Other:
• Telephone interview
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital

Biological:
• Urinary sample retrieved for biological assessment and biobanking
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital

Procedure:
• jugular and renal ultrasound (optional)
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital

Locations

Country	Name	City	State
France	CHR Metz-Thionville - Hôpital de Mercy	Metz	Lorraine
France	CHRU Nancy Hôpitaux de Brabois	Vandœuvre-lès-Nancy	Lorraine

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	at 3 months after hospital discharge
Primary	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)	at 3 months after hospital discharge
Primary	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)	at 3 months after hospital discharge
Secondary	Clinical congestion markers as assessed with the Ambrosy Score	Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Secondary	Clinical congestion markers as assessed with the ASCEND score	Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Secondary	Natriuretic peptides	Natriuretic peptides at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Secondary	Estimated plasma volume	Estimated plasma volume at admission and at final discharge	at admission and at final discharge (an average of 10 days after admission)
Secondary	Ultrasound congestion markers	B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion	at admission and at final discharge (an average of 10 days after admission)
Secondary	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%	at final discharge (an average of 10 days after admission)
Secondary	NYHA class	NYHA class (1, 2, 3, 4)	3 months after hospital discharge
Secondary	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.	3, 12 and 24 months after hospitalization
Secondary	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)	12 and 24 months after hospitalization
Secondary	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)	12 and 24 months after hospitalization
Secondary	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)	12 and 24 months after hospitalization