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AzTrials

Acute Heart FailureAHF-CODENCT04332692

Acute Heart Failure - COngestion Discharge Evaluation

A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography and 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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by… 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, Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography and Blood sample retrieved for biological assessment and biobanking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteFrance
Study dates
15 Jul 2020to 20 May 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 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)
Show all 9Show fewer
  • 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.

Nicolas GIRERD, MD,PhD contact

+ 33 3 83 15 73 22 ext. + 33 3

n.girerd@chru-nancy.fr

Sanae BOUALI, PhD contact

+ 33 3 83 15 73 22 ext. + 33 3

s.bouali@chru-nancy.fr

France1 site, 1 recruiting

  • CHRU de Nancy

    Vandœuvre-lès-Nancy, 54500

    Nicolas GIRERD, MD, PhD, +33383157322 ext. +333, n.girerd@chru-nancy.fr

    Recruiting

Other trials in France

About this study

Official title: Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.

Acute heart failure (AHF) is a major public health problem, associated with a 40% risk of death or re-hospitalisation at 3 months. This risk is significantly increased by insufficient decongestion at the end of hospitalisation for AHF assessed by a standardised clinical score, a natriuretic peptide dosage or by cardiac and pulmonary ultrasound .

Adapting treatment according to lung congestion assessed by implantable devices (not reimbursed in France) improves the prognosis. However, due to the lack of a standardised congestion assessment, therapeutic adaptation in acute heart failure is currently empirical. The best multimodality approach to congestion evaluation is uncertain.

Being tested
Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography, Blood sample retrieved for biological assessment and biobanking, Telephone follow-up, Kansas City Cardiomyopathy Questionnaire (KCCQ)
Keywords
Acute Heart Failure

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

  • Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastographyProcedure or surgery

    Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital

  • Blood sample retrieved for biological assessment and biobankingProcedure or surgery

    Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital

  • Telephone follow-upProcedure or surgery

    Telephone follow-up will be performed 3, 12 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 groups in NCT04332692
Study groupRoleWhat they receive
Patients hospitalized for acute heart failureExperimentalPatients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Receives: Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography; Procedure: Blood sample retrieved for biological assessment and biobanking; Procedure: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 2 and 3)

    Measured: 3 months after hospital discharge

  2. 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 24 months following day hospitalization (with outcome 1 and 3)

    Measured: 3 months after hospital discharge

  3. 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 1 and 2)

    Measured: 3 months after hospital discharge

Secondary outcomes (15)

  1. Rate of all-cause death

    Measured: 3, 12 and 24 months after hospital discharge

  2. Rate of re-hospitalisation for acute heart failure

    Measured: 3,12 and 24 months after hospital discharge

  3. Rate of day-hospital or in-home IV diuretics injection for acute HF

    Measured: 3,12 and 24 months after hospital discharge

  4. 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 at 12 and 24 months following hospitalization (with outcome 8 and 9)

    Measured: 12 and 24 months after hospital discharge

  5. 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 at 12 and 24 months following hospitalization (with outcome 7 and 9)

    Measured: 12 and 24 months after hospital discharge

  6. 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 at 12 and 24 months following hospitalization (with outcome 7 and 8)

    Measured: 12 and 24 months after hospital discharge.

  7. 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 11 and 12)

    Measured: 3, 12 and 24 months after hospital discharge.

  8. 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 10 and 12)

    Measured: 3, 12 and 24 months after hospital discharge.

  9. 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 10 and 11)

    Measured: 3, 12 and 24 months after hospital discharge.

  10. NYHA (New York Heart Association) class measured

    Measured: 3, 12 and 24 months after hospital discharge

  11. Natriuretic peptides

    BNP or Nt-Pro BNP

    Measured: within 24 months after hospital discharge.

  12. Renal function assessed by glomerular filtration rate

    Measured: within 24 months after hospital discharge.

  13. Plasma volume

    calculated from haemoglobin and haematocrit value

    Measured: within 24 months after hospital discharge.

  14. Liver elastography value

    Measured with Fibroscan

    Measured: At inclusion

  15. Quality of life

    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.

  1. First posted3 Apr 2020
  2. Study start15 Jul 2020
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion20 May 2028 (estimated)

Resources

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
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04332692
Sponsor's protocol ID
2019-A03311-56
Acronym
AHF-CODE
Status last verified
Mar 2023
First submitted
12 Mar 2020
Last updated
5 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical examination centered on congestion, Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography and 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 5 inclusion and 9 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, MD,PhD (+ 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?

On the ClinicalTrials.gov record for NCT04332692.

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.

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