AHF-CODE: Acute Heart Failure - COngestion Discharge Evaluation
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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, 12 and 24 months after discharge from hospital
|
Outcome Measures
Primary Outcome Measures
- Rate of all-cause death [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 day hospitalization (with outcome 2 and 3)
- Rate of re-hospitalisation for acute heart failure [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 day hospitalization (with outcome 1 and 3)
- Rate of day-hospital or in-home IV diuretics injection for acute HF [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 day hospitalization (with outcome 1 and 2)
Secondary Outcome Measures
- Rate of all-cause death [3, 12 and 24 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [3,12 and 24 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [3,12 and 24 months after hospital discharge]
- Rate of all-cause death [12 and 24 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 at 12 and 24 months following hospitalization (with outcome 8 and 9)
- Rate of re-hospitalisation for acute heart failure [12 and 24 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 at 12 and 24 months following hospitalization (with outcome 7 and 9)
- Rate of day-hospital or in-home IV diuretics injection for acute HF [12 and 24 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 at 12 and 24 months following hospitalization (with outcome 7 and 8)
- Rate of all-cause death [3, 12 and 24 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 day hospitalization (with outcome 11 and 12)
- Rate of hospitalization for acute heart failure [3, 12 and 24 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 day hospitalization (with outcome 10 and 12)
- Rate of day-hospital or in-home IV diuretics injection for acute HF [3, 12 and 24 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 day hospitalization (with outcome 10 and 11)
- NYHA (New York Heart Association) class measured [3, 12 and 24 months after hospital discharge]
- Natriuretic peptides [within 24 months after hospital discharge.]
BNP or Nt-Pro BNP
- Renal function assessed by glomerular filtration rate [within 24 months after hospital discharge.]
- Plasma volume [within 24 months after hospital discharge.]
calculated from haemoglobin and haematocrit value
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients hospitalised for acute heart failure.
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Patients considered clinically discharging from hospitalisation for acute heart failure.
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Age ≥18 years
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Patients having received complete information regarding the study design and having signed their informed consent form.
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Patient affiliated to or beneficiary of a social security scheme.
Exclusion Criteria:
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Comorbidity for which the life expectancy is ≤ 3 months
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Dialysis patient (peritoneal dialysis or hemodialysis) or patients with glomerular filtration rate <15 ml/min/m2 at inclusion.
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History of lobectomy or pneumonectomy lung surgery
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Severe pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis, etc.
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Pregnant woman, parturient or nursing mother
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Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
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Adult person who is unable to give consent
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Person deprived of liberty by a judicial or administrative decision,
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Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU de Nancy | Vandoeuvre Les Nancy | France | 54500 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
- Principal Investigator: Nicolas GIRERD, MD,PhD, CHRU of Nancy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-A03311-56