Acute Heart Failure - COngestion Discharge Evaluation

Acute Heart Failure Clinical Trial

— AHF-CODE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04332692
• Other study ID #: 2019-A03311-56
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: May 20, 2028

Study information

• Verified date: March 2023
• Source: Central Hospital, Nancy, France
• Contact: Nicolas GIRERD, MD,PhD
• Phone: + 33 3 83 15 73 22
• Email: n.girerd[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: May 20, 2028
• Est. primary completion date: August 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Procedure:
• 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

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

Locations

Country	Name	City	State
France	CHRU de Nancy	Vandoeuvre Les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

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