Acute Heart Failure - COngestion Discharge Evaluation

Not Applicable

Recruiting

• Conditions: Acute Heart Failure
• Interventions: Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography; Procedure: Blood sample retrieved for biological assessment and biobanking; Procedure: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

• Registration Number: NCT04332692
• Lead Sponsor: Central Hospital, Nancy, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-03
• Study Start: 2020-07-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-06-02
• Last Update Posted: 2023-06-05
• Primary Completion: 2026-08-20
• Study Completion: 2028-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients hospitalized for acute heart failure	Clinical examination centered on congestion	Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients hospitalized for acute heart failure	Blood sample retrieved for biological assessment and biobanking	Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients hospitalized for acute heart failure	Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography	Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients hospitalized for acute heart failure	Telephone follow-up	Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up
Patients hospitalized for acute heart failure	Kansas City Cardiomyopathy Questionnaire (KCCQ)	Patients hospitalized for acute heart failure will undergo the following evaluations: * Clinical examination focusing on congestion * Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds * Blood sample retrieved for biological assessment and biobanking * Telephone follow-up

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Rate of all-cause death	3, 12 and 24 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 11 and 12)
NYHA (New York Heart Association) class measured	3, 12 and 24 months after hospital discharge
Liver elastography value	At inclusion	Measured with Fibroscan
Renal function assessed by glomerular filtration rate	within 24 months after hospital discharge.
Rate of day-hospital or in-home IV diuretics injection for acute HF	3, 12 and 24 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 10 and 11)
Rate of hospitalization for acute heart failure	3, 12 and 24 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 10 and 12)
Plasma volume	within 24 months after hospital discharge.	calculated from haemoglobin and haematocrit value
Rate of re-hospitalisation for acute heart failure	12 and 24 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 at 12 and 24 months following hospitalization (with outcome 7 and 9)
Natriuretic peptides	within 24 months after hospital discharge.	BNP or Nt-Pro BNP
Quality of life	At inclusion and 3, 6 and 24 months	Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Trial Locations

Locations (1)

CHRU de Nancy; 🇫🇷 Vandoeuvre Les Nancy, France