Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation

Acute Heart Failure Clinical Trial

— AHF-CODE-R  

Official title:

Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë à Fraction d'éjection altérée ou modérément altérée

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343443
• Other study ID #: 2019PI188-3
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2020
• Est. completion date: August 21, 2028

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 21, 2028
• Est. primary completion date: August 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients hospitalised for acute heart failure.
• Patients with reduced ejection fraction (Ejection Fraction <40%) or (40% = Ejection Fraction < 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.

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
• 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

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 3 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 3 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 3 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 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 or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 8)	3, 12 and 24 months after hospital discharge
Secondary	Rate of hospitalisation for acute heart failure	composite endpoint : Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 7)	3, 12 and 24 months after hospital discharge
Secondary	Rate of all-cause death	composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 10)	3, 12 and 24 months after hospital discharge
Secondary	Rate of hospitalisation for acute heart failure	composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 9)	3, 12 and 24 months after hospital discharge
Secondary	NYHA (New York Heart Association) class		3, 12 and 24 months after hospital discharge
Secondary	Natriuretic peptides	BNP or Nt-Pro BNP	At inclusion
Secondary	Renal function assessed by glomerular filtration rate		At inclusion
Secondary	Plasma volume	calculated from haemoglobin and haematocrit value	At inclusion
Secondary	Blood potassium		At inclusion
Secondary	Rate of all-cause death	composite endpoint: Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 17)	3, 12 and 24 months after hospital discharge
Secondary	Rate of hospitalisation for acute heart failure	composite endpoint : Rate of all-cause death or hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 16)	3, 12 and 24 months after hospital discharge
Secondary	Liver elastography value	Measured with Fibroscan®	At inclusion
Secondary	Quality of life assessed by Kansas City Cardiomyopathy Questionnaire	Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At inclusion and 3, 6 and 24 months