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

Primary Purpose

Acute Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical examination centered on congestion
Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Blood sample retrieved for biological assessment and biobanking
Telephone follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Heart Failure focused on measuring Acute Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRU de NancyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients hospitalized for acute heart failure

Arm Description

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

Outcomes

Primary Outcome Measures

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)
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)
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)

Secondary Outcome Measures

Rate of all-cause death
Rate of re-hospitalisation for acute heart failure
Rate of day-hospital or in-home IV diuretics injection for acute HF
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)
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)
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)
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)
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)
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)
NYHA (New York Heart Association) class measured
Natriuretic peptides
BNP or Nt-Pro BNP
Renal function assessed by glomerular filtration rate
Plasma volume
calculated from haemoglobin and haematocrit value
Liver elastography value
Measured with Fibroscan
Quality of life
Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Full Information

First Posted
March 12, 2020
Last Updated
June 2, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04332692
Brief Title
Acute Heart Failure - COngestion Discharge Evaluation
Acronym
AHF-CODE
Official Title
Acute Heart Failure - COngestion Discharge Evaluation. Évaluation de la Congestion à la Sortie d'Hospitalisation Pour Insuffisance Cardiaque aiguë.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
August 20, 2026 (Anticipated)
Study Completion Date
May 20, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Acute Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients hospitalized for acute heart failure
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Clinical examination centered on congestion
Intervention Description
Clinical examination centered on congestion (ASCEND, NYHA and Ambrosy Score) will be performed before discharge from hospital
Intervention Type
Procedure
Intervention Name(s)
Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Intervention Description
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed before discharge from hospital
Intervention Type
Procedure
Intervention Name(s)
Blood sample retrieved for biological assessment and biobanking
Intervention Description
Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital
Intervention Type
Procedure
Intervention Name(s)
Telephone follow-up
Intervention Description
Telephone follow-up will be performed 3, 12 and 24 months after discharge from hospital
Intervention Type
Behavioral
Intervention Name(s)
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Intervention Description
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Primary Outcome Measure Information:
Title
Rate of all-cause death
Description
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)
Time Frame
3 months after hospital discharge
Title
Rate of re-hospitalisation for acute heart failure
Description
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)
Time Frame
3 months after hospital discharge
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
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)
Time Frame
3 months after hospital discharge
Secondary Outcome Measure Information:
Title
Rate of all-cause death
Time Frame
3, 12 and 24 months after hospital discharge
Title
Rate of re-hospitalisation for acute heart failure
Time Frame
3,12 and 24 months after hospital discharge
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time Frame
3,12 and 24 months after hospital discharge
Title
Rate of all-cause death
Description
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)
Time Frame
12 and 24 months after hospital discharge
Title
Rate of re-hospitalisation for acute heart failure
Description
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)
Time Frame
12 and 24 months after hospital discharge
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
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)
Time Frame
12 and 24 months after hospital discharge.
Title
Rate of all-cause death
Description
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)
Time Frame
3, 12 and 24 months after hospital discharge.
Title
Rate of hospitalization for acute heart failure
Description
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)
Time Frame
3, 12 and 24 months after hospital discharge.
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
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)
Time Frame
3, 12 and 24 months after hospital discharge.
Title
NYHA (New York Heart Association) class measured
Time Frame
3, 12 and 24 months after hospital discharge
Title
Natriuretic peptides
Description
BNP or Nt-Pro BNP
Time Frame
within 24 months after hospital discharge.
Title
Renal function assessed by glomerular filtration rate
Time Frame
within 24 months after hospital discharge.
Title
Plasma volume
Description
calculated from haemoglobin and haematocrit value
Time Frame
within 24 months after hospital discharge.
Title
Liver elastography value
Description
Measured with Fibroscan
Time Frame
At inclusion
Title
Quality of life
Description
Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame
At inclusion and 3, 6 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas GIRERD, MD,PhD
Phone
+ 33 3 83 15 73 22
Ext
+ 33 3
Email
n.girerd@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sanae BOUALI, PhD
Phone
+ 33 3 83 15 73 22
Ext
+ 33 3
Email
s.bouali@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD,PhD
Organizational Affiliation
CHRU of Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas GIRERD, MD, PhD
Phone
+33383157322
Ext
+333
Email
n.girerd@chru-nancy.fr

12. IPD Sharing Statement

Learn more about this trial

Acute Heart Failure - COngestion Discharge Evaluation

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