Acute Heart Failure - COngestion Discharge Evaluation

Recruiting · NCT04332692 · Interventional (participants receive a specific treatment) · Lead sponsor: Central Hospital, Nancy, France

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Heart failure

Interventions studied

Blood sample retrieved for biological assessment and biobankingCardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastographyClinical examination centered on congestionKansas City Cardiomyopathy Questionnaire (KCCQ)Telephone follow-up

What this trial is about

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.

Who can take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

CHRU de Nancy - Vandœuvre-lès-Nancy, France

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →