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Acute Heart Failure - COngestion Discharge Evaluation (AHF-CODE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04332692
Recruitment Status : Not yet recruiting
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief 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 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.


Condition or disease Intervention/treatment Phase
Acute Heart Failure Procedure: Clinical examination centered on congestion Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds Procedure: Blood sample retrieved for biological assessment and biobanking Procedure: Telephone follow-up Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Estimated Study Start Date : April 20, 2020
Estimated Primary Completion Date : August 20, 2024
Estimated Study Completion Date : May 20, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Patients hospitalized for acute heart failure

Patients 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
Procedure: Clinical examination centered on congestion
Clinical examination centered on congestion will be performed before discharge from hospital

Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds
Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed before discharge from hospital

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

Procedure: Telephone follow-up
Telephone follow-up will be performed 3 months and 12 months after discharge from hospital




Primary Outcome Measures :
  1. Rate of death from all causes [ Time Frame: 3 months after hospital discharge ]
    composite endpoint : rate of death from all causes or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2)

  2. Rate of re-hospitalisation for acute heart failure [ Time Frame: 3 months after hospital discharge ]
    composite endpoint : rate of death from all causes or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 1)


Secondary Outcome Measures :
  1. Rate of death from all causes [ Time Frame: 3 and 12 months after hospital discharge ]
  2. Rate of re-hospitalisation for acute heart failure [ Time Frame: 3 and 12 months after hospital discharge. ]
  3. Rate of death from all causes [ Time Frame: 12 months after hospital discharge ]
    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure at 12 months after hospital discharge (with outcome 6)

  4. Rate of hospitalisation for acute heart failure [ Time Frame: 12 months after hospital discharge. ]
    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure at 12 months after hospital discharge (with outcome 5)

  5. Rate of death from all causes [ Time Frame: 3 months after hospital discharge. ]
    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 8)

  6. Rate of hospitalisation for acute heart failure [ Time Frame: 3 months after hospital discharge. ]
    composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 7)

  7. NYHA (New York Heart Association) class measured [ Time Frame: 3 and 12 months after hospital discharge ]
  8. Natriuretic peptides [ Time Frame: within 12 months after hospital discharge. ]
    BNP or Nt-Pro BNP

  9. Renal function assessed by glomerular filtration rate [ Time Frame: within 12 months after hospital discharge. ]
  10. Plasma volume [ Time Frame: within 12 months after hospital discharge. ]
    calculated from haemoglobin and haematocrit value

  11. Blood potassium [ Time Frame: within 12 months after hospital discharge. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Valvulopathy causing decompensation of heart failure for which intervention is being considered.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04332692


Contacts
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Contact: Nicolas GIRERD, MD,PhD + 33 3 83 15 73 22 ext + 33 3 n.girerd@chru-nancy.fr
Contact: Sanae BOUALI, PhD + 33 3 83 15 73 22 ext + 33 3 s.bouali@chru-nancy.fr

Locations
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France
CHRU de Nancy
Vandoeuvre Les Nancy, France, 54500
Contact: Nicolas GIRERD, MD, PhD    +33383157322 ext +333    n.girerd@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Nicolas GIRERD, MD,PhD CHRU of Nancy

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04332692    
Other Study ID Numbers: 2019-A03311-56
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
Acute Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases