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Recruiting Not applicable

Acute Heart Failure - COngestion Discharge Evaluation

NCT04332692 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-07-15
Last updated
2023-06-05

Condition(s) studied

Acute Heart Failure

Investigational drug(s) / intervention(s)

Clinical examination centered on congestionCardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastographyBlood sample retrieved for biological assessment and biobankingTelephone follow-upKansas City Cardiomyopathy Questionnaire (KCCQ)

Clinical examination centered on congestion: Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital

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

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

Telephone follow-up: Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital

Kansas City Cardiomyopathy Questionnaire (KCCQ): Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge

Study 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. The best multimodality approach to congestion evaluation is uncertain.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
CHRU de Nancy Vandœuvre-lès-Nancy France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04332692 on ClinicalTrials.gov ↗ ← All trials in France