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Recruiting Not applicable

Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation

NCT04343430 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2020-08-29
Last updated
2023-06-05

Condition(s) studied

Acute Heart Failure

Investigational drug(s) / intervention(s)

Clinical examination centered on congestionCardio-pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastographyBiological: Blood sample retrieved for biological assessment and biobankingTelephone interviewKansas 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

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

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

Telephone interview: Telephone interview will be performed at 3, 12 months 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

The AHF-CODE preserved study is a prospective, non-randomized, monocenter study performed in patients with heart failure with preserved ejection fraction admitted for worsening heart failure.

The main objective of the AHF-CODE preserved 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients hospitalised for acute heart failure. * Patient with preserved ejection fraction (FE ≥ 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.

Primary outcome measure(s)

  • Rate of all-cause death — 3 months after hospital discharge
    composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)

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 NCT04343430 on ClinicalTrials.gov ↗ ← All trials in France