Acute Heart FailureAHF-CORENCT03327532
Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE)
A study testing Clinical examination centered on congestion, Cardio-pulmonary and peritoneal ultrasound and Blood sample retrieved for biological assessment and biobanking in people with Acute Heart Failure, run by Central Hospital, Nancy, France at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- What is being tested?
- Clinical examination centered on congestion, Cardio-pulmonary and peritoneal ultrasound and Blood sample retrieved for biological assessment and biobanking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2018to Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CHR Metz-Thionville - Hôpital de Mercy
Metz, Lorraine, 57000
Noura ZANNAD, MD
- Recruiting
CHRU Nancy Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, 54500
Nicolas GIRERD, MD
About this study
Official title: Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
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.
Read more
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
Read the 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.
- Conditions
- Acute Heart Failure
- Being tested
- 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
- Keywords
- Acute Heart Failure, Congestion, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examination centered on congestionProcedure or surgery
Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
Cardio-pulmonary and peritoneal ultrasoundProcedure or surgery
Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
Blood sample retrieved for biological assessment and biobankingBiological
Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
Telephone interviewOther
Telephone interview will be performed 3, 12 and 24 months after discharge from hospital
Urinary sample retrieved for biological assessment and biobankingBiological
Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
jugular and renal ultrasound (optional)Procedure or surgery
optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for acute heart failure | Experimental | 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 Receives: Procedure: Clinical examination centered on congestion; Procedure: Cardio-pulmonary and peritoneal ultrasound; Biological: Blood sample retrieved for biological assessment and biobanking; Other: Telephone interview; Biological: Urinary sample retrieved for biological assessment and biobanking; Procedure: jugular and renal ultrasound (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: at 3 months after hospital discharge
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)
Measured: at 3 months after hospital discharge
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)
Measured: at 3 months after hospital discharge
Secondary outcomes (11)
Clinical congestion markers as assessed with the Ambrosy Score
Clinical congestion markers as assessed with the Ambrosy Score at admission and at final discharge
Measured: at admission and at final discharge (an average of 10 days after admission)
Clinical congestion markers as assessed with the ASCEND score
Clinical congestion markers as assessed with the ASCEND score at admission and at final discharge
Measured: at admission and at final discharge (an average of 10 days after admission)
Natriuretic peptides
Natriuretic peptides at admission and at final discharge
Measured: at admission and at final discharge (an average of 10 days after admission)
Estimated plasma volume
Estimated plasma volume at admission and at final discharge
Measured: at admission and at final discharge (an average of 10 days after admission)
Ultrasound congestion markers
B lines, pleural effusion, E/e', DTE, TRV, VCI, Jugular diameter, renal venous blood flow pattern, peritoneal effusion
Measured: at admission and at final discharge (an average of 10 days after admission)
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%
Measured: at final discharge (an average of 10 days after admission)
NYHA class
NYHA class (1, 2, 3, 4)
Measured: 3 months after hospital discharge
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.
Measured: 3, 12 and 24 months after hospitalization
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)
Measured: 12 and 24 months after hospitalization
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)
Measured: 12 and 24 months after hospitalization
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)
Measured: 12 and 24 months after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start13 Feb 2018
- Primary completionMay 2024 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Nicolas GIRERD, Central Hospital, Nancy, France
- Investigators
- Nicolas GIRERD, MD,PhD, Principal investigator, Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327532
- Sponsor's protocol ID
- 2017-A01455-48
- Acronym
- AHF-CORE
- Status last verified
- Aug 2023
- First submitted
- 6 Sep 2017
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
- ClinicalTrials.gov ID
- NCT03327532
- Acronym / sponsor ID
- AHF-CORE / 2017-A01455-48
- Conditions
- Acute Heart Failure
- Keywords
- Acute Heart Failure, Congestion, Ultrasound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for acute heart failure | Experimental | Procedure: Clinical examination centered on congestion, Procedure: Cardio-pulmonary and peritoneal ultrasound, Biological: Blood sample retrieved for biological assessment and biobanking, Other: Telephone interview, Biological: Urinary sample retrieved for biological assessment and biobanking, Procedure: jugular and renal ultrasound (optional)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examination centered on congestionClinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Cardio-pulmonary and peritoneal ultrasoundCardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Blood sample retrieved for biological assessment and biobankingBlood sample collection will be performed within 72 hours of admission and before discharge from hospital | Biological | Patients hospitalized for acute heart failure |
| Telephone interviewTelephone interview will be performed 3, 12 and 24 months after discharge from hospital | Other | Patients hospitalized for acute heart failure |
| Urinary sample retrieved for biological assessment and biobankingUrinary sample collection will be performed within 72 hours of admission and before discharge from hospital | Biological | Patients hospitalized for acute heart failure |
| jugular and renal ultrasound (optional)optional jugular and renal ultrasound performed within 72hours of admission and before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
Primary outcome
Rate of all-cause death
Time frame: at 3 months after hospital discharge
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
Time frame: at 3 months after hospital discharge
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
Time frame: at 3 months after hospital discharge
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)
11 secondary outcomes
Clinical congestion markers as assessed with the Ambrosy Score
Time frame: at admission and at final discharge (an average of 10 days after admission)
Clinical congestion markers as assessed with the ASCEND score
Time frame: at admission and at final discharge (an average of 10 days after admission)
Natriuretic peptides
Time frame: at admission and at final discharge (an average of 10 days after admission)
Estimated plasma volume
Time frame: at admission and at final discharge (an average of 10 days after admission)
Ultrasound congestion markers
Time frame: at admission and at final discharge (an average of 10 days after admission)
Residual congestion
Time frame: at final discharge (an average of 10 days after admission)
NYHA class
Time frame: 3 months after hospital discharge
Rate of day-hospital for Intravenous diuretics administration for acute HF
Time frame: 3, 12 and 24 months after hospitalization
Rate of all-cause death
Time frame: 12 and 24 months after hospitalization
Rate of hospitalization for acute heart failure
Time frame: 12 and 24 months after hospitalization
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time frame: 12 and 24 months after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Heart Failure
Not yet recruiting
Routine Magnesium Testing and Supplementation in Acute Heart Failure (MAG-HF)
Acute Heart Failure (AHF)
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas GIRERD, MD,PhD principal investigator
Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination centered on congestion, Cardio-pulmonary and peritoneal ultrasound and Blood sample retrieved for biological assessment and biobanking in people with Acute Heart Failure, run by Central Hospital, Nancy, France at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GIRERD, MD,PhD (+ 33 3 83 15 74 96 ext. + 33 3, n.girerd@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause death (time frame: at 3 months after hospital discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.