Acute Heart Failure - COngestion Discharge Evaluation (AHF-CODE)

Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sanae BOUALI, PhD; Phone Number: + 33 3 + 33 3 83 15 73 22; Email: s.bouali@chru-nancy.fr
• Study Contact Backup: Name: Nicolas GIRERD, MD,PhD; Phone Number: + 33 3 + 33 3 83 15 73 22; Email: n.girerd@chru-nancy.fr

Study Locations

• France
  • Vandoeuvre Les Nancy, France, 54500
    • Recruiting
    • CHRU de Nancy
    • Contact: Nicolas GIRERD, MD, PhD; Phone Number: +333 +33383157322; Email: n.girerd@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients hospitalized for acute heart failure; 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

Procedure: Blood sample retrieved for biological assessment and biobanking; Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital; Procedure: Telephone follow-up; Telephone follow-up will be performed 3, 12 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; Procedure: Clinical examination centered on congestion; Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause death	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)	3 months after hospital discharge
Rate of re-hospitalisation for acute heart failure	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)	3 months after hospital discharge
Rate of day-hospital or in-home IV diuretics injection for acute HF	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)	3 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all-cause death		3, 12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure		3,12 and 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
Rate of all-cause death	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 8 and 9)	12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure	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)	12 and 24 months after hospital discharge
Rate of day-hospital or in-home IV diuretics injection for acute HF	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 8)	12 and 24 months after hospital discharge.
Rate of all-cause death	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)	3, 12 and 24 months after hospital discharge.
Rate of hospitalization for acute heart failure	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)	3, 12 and 24 months after hospital discharge.
Rate of day-hospital or in-home IV diuretics injection for acute HF	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)	3, 12 and 24 months after hospital discharge.
NYHA (New York Heart Association) class measured		3, 12 and 24 months after hospital discharge
Natriuretic peptides	BNP or Nt-Pro BNP	within 24 months after hospital discharge.
Renal function assessed by glomerular filtration rate		within 24 months after hospital discharge.
Plasma volume	calculated from haemoglobin and haematocrit value	within 24 months after hospital discharge.
Liver elastography value	Measured with Fibroscan	At inclusion
Quality of life	Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At inclusion and 3, 6 and 24 months

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Nicolas GIRERD, MD,PhD, CHRU of Nancy

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): May 20, 2028

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 31, 2020
• First Posted (Actual): April 3, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Acute Heart Failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019-A03311-56

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No