Recruiting NCT04343443
Acute Heart Failure With Reduced Ejection Fraction - 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, Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography, Biological: Blood sample retrieved for biological assessment and biobanking, Telephone interview.
- 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 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
Overview
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.
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 Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography
Cardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital - Procedure Biological: Blood sample retrieved for biological assessment and biobanking
Blood sample collection will be performed before discharge from hospital - Procedure Telephone interview
Telephone interview will be performed at 3, 12 months 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 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]
Eligibility criteria
Inclusion criteria
- 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.
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: NCT04343443 · 2019PI188-3