Acute Heart FailureAHF-CODE-RNCT04343443
Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation
A study testing Clinical examination centered on congestion, Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Biological: Blood sample retrieved for biological assessment and biobanking in people with Acute Heart Failure, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure. 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, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Biological: Blood sample retrieved for biological assessment and biobanking
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2020to 21 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 hospitalised for acute heart failure.
- Patients with reduced ejection fraction (Ejection Fraction <40%) or (40% ≤ Ejection Fraction < 50)
- Patients considered clinically discharging from hospitalisation for acute heart failure.
- Age ≥18 years
- Patients having received complete information regarding the study design and having signed their informed consent form.
- Patient affiliated to or beneficiary of a social security scheme.
Who cannot join
- Comorbidity for which the life expectancy is ≤ 3 months
- Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- Pregnant woman, parturient or nursing mother
- Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) Adult person who is unable to give consent
- Person deprived of liberty by a judicial or administrative decision,
- Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Vandœuvre-lès-Nancy, 54500
Nicolas GIRERD, MD,PhD, +33383157322 ext. +333, n.girerd@chru-nancy.fr
Nicolas GIRERD, MD,PhD
About this study
Official title: Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection altérée ou modérément altérée
The AHF-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure.
The main objective of the AHF-CODE study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
- Conditions
- Acute Heart Failure
- Being tested
- Clinical examination centered on congestion, Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Biological: Blood sample retrieved for biological assessment and biobanking, Telephone interview, Kansas City Cardiomyopathy Questionnaire (KCCQ)
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 (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyProcedure or surgery
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital
Biological: Blood sample retrieved for biological assessment and biobankingProcedure or surgery
Blood sample collection will be performed before discharge from hospital
Telephone interviewProcedure or surgery
Telephone interview will be performed at 3, 12 months and 24 months after discharge from hospital
Kansas City Cardiomyopathy Questionnaire (KCCQ)Behavioural
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized for acute heart failure | Other | Patients hospitalized for acute heart failure will undergo the following evaluations:
* Clinical examination centered on congestion
* Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds
* Blood sample retrieved for biological assessment and biobanking
* Telephone interview Receives: Procedure: Clinical examination centered on congestion; Procedure: Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography; Procedure: Biological: Blood sample retrieved for biological assessment and biobanking; Procedure: Telephone interview; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ) |
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 3 months following day hospitalization (with outcome 2 and 3)
Measured: 3 months after hospital discharge
Rate of re-hospitalisation 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 3 months following day hospitalization (with outcome 1 and 3)
Measured: 3 months after hospital discharge
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 3 months following day hospitalization (with outcome 1 and 2)
Measured: 3 months after hospital discharge
Secondary outcomes (16)
Rate of all-cause death
Measured: 3, 12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure
Measured: 3, 12 and 24 months after hospital discharge
Rate of day-hospital IV diuretics injection for acute HF
Measured: 3, 12 and 24 months after hospital discharge
Rate of all-cause death
composite endpoint : Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 8)
Measured: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
composite endpoint : Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 7)
Measured: 3, 12 and 24 months after hospital discharge
Rate of all-cause death
composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 10)
Measured: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 9)
Measured: 3, 12 and 24 months after hospital discharge
NYHA (New York Heart Association) class
Measured: 3, 12 and 24 months after hospital discharge
Natriuretic peptides
BNP or Nt-Pro BNP
Measured: At inclusion
Renal function assessed by glomerular filtration rate
Measured: At inclusion
Plasma volume
calculated from haemoglobin and haematocrit value
Measured: At inclusion
Blood potassium
Measured: At inclusion
Rate of all-cause death
composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 17)
Measured: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
composite endpoint : Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 16)
Measured: 3, 12 and 24 months after hospital discharge
Liver elastography value
Measured with Fibroscan®
Measured: At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Measured: At inclusion and 3, 6 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start21 Aug 2020
- Primary completion21 Aug 2026 (estimated)
- Study completion21 Aug 2028 (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.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343443
- Sponsor's protocol ID
- 2019PI188-3
- Acronym
- AHF-CODE-R
- Status last verified
- Mar 2023
- First submitted
- 9 Apr 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection altérée ou modérément altérée
- ClinicalTrials.gov ID
- NCT04343443
- Acronym / sponsor ID
- AHF-CODE-R / 2019PI188-3
- Conditions
- Acute Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 21 Aug 2020 (actual)
- Primary completion
- 21 Aug 2026 (estimated)
- Study completion
- 21 Aug 2028 (estimated)
- First posted
- 13 Apr 2020 (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-CODE reduced study is a prospective, non-randomized, monocenter study performed in patients with heart failure with reduced ejection fraction admitted for worsening heart failure.
The main objective of the AHF-CODE study is to identify congestion markers (clinical, biological and ultrasound) at the end of hospitalization for acute heart failure that are associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized for acute heart failure | Other | Procedure: Clinical examination centered on congestion, Procedure: Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Procedure: Biological: Blood sample retrieved for biological assessment and biobanking, Procedure: Telephone interview, Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination centered on congestion * Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds * 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 (6 listed)
- Patients hospitalised for acute heart failure.
- Patients with reduced ejection fraction (Ejection Fraction <40%) or (40% ≤ Ejection Fraction < 50)
- Patients considered clinically discharging from hospitalisation for acute heart failure.
- Age ≥18 years
- Patients having received complete information regarding the study design and having signed their informed consent form.
Key exclusion criteria (8 listed)
- Comorbidity for which the life expectancy is ≤ 3 months
- Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
- History of lobectomy or pneumonectomy lung surgery
- Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
- Pregnant woman, parturient or nursing mother
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 (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyCardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Biological: Blood sample retrieved for biological assessment and biobankingBlood sample collection will be performed before discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Telephone interviewTelephone interview will be performed at 3, 12 months and 24 months after discharge from hospital | Procedure or surgery | Patients hospitalized for acute heart failure |
| Kansas City Cardiomyopathy Questionnaire (KCCQ)Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge | Behavioural | Patients hospitalized for acute heart failure |
Primary outcome
Rate of all-cause death
Time frame: 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 3 months following day hospitalization (with outcome 2 and 3)
Rate of re-hospitalisation for acute heart failure
Time frame: 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 3 months following day hospitalization (with outcome 1 and 3)
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time frame: 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 3 months following day hospitalization (with outcome 1 and 2)
16 secondary outcomes
Rate of all-cause death
Time frame: 3, 12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure
Time frame: 3, 12 and 24 months after hospital discharge
Rate of day-hospital IV diuretics injection for acute HF
Time frame: 3, 12 and 24 months after hospital discharge
Rate of all-cause death
Time frame: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
Time frame: 3, 12 and 24 months after hospital discharge
Rate of all-cause death
Time frame: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
Time frame: 3, 12 and 24 months after hospital discharge
NYHA (New York Heart Association) class
Time frame: 3, 12 and 24 months after hospital discharge
Natriuretic peptides
Time frame: At inclusion
Renal function assessed by glomerular filtration rate
Time frame: At inclusion
Plasma volume
Time frame: At inclusion
Blood potassium
Time frame: At inclusion
Rate of all-cause death
Time frame: 3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure
Time frame: 3, 12 and 24 months after hospital discharge
Liver elastography value
Time frame: At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire
Time frame: At inclusion and 3, 6 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
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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.
1 site 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, peritoneal, jugular and renal Doppler ultrasounds and liver elastography and Biological: Blood sample retrieved for biological assessment and biobanking in people with Acute Heart Failure, run by Central Hospital, Nancy, France at 1 site 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas GIRERD (+ 33 3 83 15 73 22 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: 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 5 Jun 2023.