Acute Heart Failure With Preserved Ejection Fraction - COngestion Discharge Evaluation (AHF-CODE-P)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

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

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.
• 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.

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

Other: Patients hospitalized for acute heart failure; Patients hospitalized for acute heart failure will undergo the following evaluations: Clinical examination centered on congestion; Cardiopulmonary , peritoneal , jugular and renal venous Doppler ultrasounds; Blood sample retrieved for biological assessment and biobanking; Telephone interview

Procedure: Biological: Blood sample retrieved for biological assessment and biobanking; Blood sample collection will be performed before discharge from hospital; Procedure: 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; Procedure: Clinical examination centered on congestion; Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital; Procedure: 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

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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (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 or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 2 and 3)	3 months after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of hospitalisation for acute heart failure	Rate of hospitalisation for acute heart Failure at 3, 12 and 24 months after hospital discharge	3, 12 and 24 months after hospital discharge
NYHA (New York Heart Association) class		3, 12 and 24 months after hospital discharge
Natriuretic peptides	BNP or Nt-Pro BNP	At inclusion
Renal function assessed by glomerular filtration rate		At inclusion
Plasma volume	Calculated from haemoglobin and haematocrit value	At inclusion
Liver elastography value	Measured with Fibroscan®	At inclusion
Blood potassium		At inclusion
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire	Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)	At inclusion and 3, 6 and 24 months
Rate of all-cause death	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3,12 and 24 months after hospital discharge (with outcome 5)	3, 12 and 24 months after hospital discharge
Rate of re-hospitalisation for acute heart failure	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 4)	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	Rate of all-cause death at 3, 12 and 24 months after hospital discharge	3, 12 and 24 months after hospital discharge
Rate of all-cause death	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 10)	3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3 months after hospital discharge (with outcome 9)	3, 12 and 24 months after hospital discharge
Rate of death from all causes	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 12)	3, 12 and 24 months after hospital discharge
Rate of hospitalisation for acute heart failure	composite endpoint : rate of all-cause death or re-hospitalisation for acute heart failure at 3, 12 and 24 months after hospital discharge (with outcome 11)	3, 12 and 24 months after hospital discharge

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2020
• Primary Completion (Estimated): August 29, 2026
• Study Completion (Estimated): August 29, 2028

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 13, 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

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2019PI188-2

Drug and device information, study documents

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