Acute Heart Failure - COngestion Discharge Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Overview
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.
Interventions
- Procedure Clinical examination centered on congestion
Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital - Procedure Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography 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 - Behavioral Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Primary outcome measures
- Rate of all-cause death [Time frame: 3 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [Time frame: 3 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Time frame: 3 months after hospital discharge]
Secondary outcome measures (12)
- 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 or in-home IV diuretics injection for acute HF [Time frame: 3,12 and 24 months after hospital discharge]
- Rate of all-cause death [Time frame: 12 and 24 months after hospital discharge]
- Rate of re-hospitalisation for acute heart failure [Time frame: 12 and 24 months after hospital discharge]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Time frame: 12 and 24 months after hospital discharge.]
- Rate of all-cause death [Time frame: 3, 12 and 24 months after hospital discharge.]
- Rate of hospitalization for acute heart failure [Time frame: 3, 12 and 24 months after hospital discharge.]
- Rate of day-hospital or in-home IV diuretics injection for acute HF [Time frame: 3, 12 and 24 months after hospital discharge.]
- NYHA (New York Heart Association) class measured [Time frame: 3, 12 and 24 months after hospital discharge]
- Natriuretic peptides [Time frame: within 24 months after hospital discharge.]
- Renal function assessed by glomerular filtration rate [Time frame: within 24 months after hospital discharge.]
Eligibility 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHRU de Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT04332692 · 2019-A03311-56