Back to resultsCHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation) (CHF-COVReduced)
Primary Purpose
Chronic Heart Failure, Reduced Ventricular Ejection Fraction
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical examination centered on congestion
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds
Blood sample retrieved for biological assessment and biobanking
Telephone follow-up
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization
- Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
- 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 with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Arm Description
Outcomes
Primary Outcome Measures
Rate of death from all causes
composite endpoint : rate of death from all causes, hospitalisation 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 hospitalisation for acute heart failure
composite endpoint : rate of death from all causes, hospitalisation 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 death from all causes, hospitalisation 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 death from all causes
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)
Rate of hospitalisation for acute heart failure
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4)
Rate of death from all causes
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 8)
Rate of day-hospital or in-home IV diuretics injection for acute HF
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 7)
Rate of hospitalisation for cardiovascular reason
Rate of death from all causes
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 11)
Rate of hospitalisation for acute heart failure
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 10)
Rate of cardiovascular death
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
Rate of Bilirubin
Rate of ASAT
Rate of ALAT
Rate of V factor
Blood potassium concentration
Circulating NtProBNP
Liver elastography value
Measured with Fibroscan®
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05089162
Brief Title
CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Acronym
CHF-COVReduced
Official Title
Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
December 14, 2028 (Anticipated)
Study Completion Date
June 14, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Pr. Nicolas GIRERD
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
Heart failure (HF) is a significant cause of death and the leading cause of hospitalization in patients over 65 years of age. Congestion is the main source of symptoms and the leading cause of hospitalization for HF. Furthermore, congestive signs identified in asymptomatic patients are associated with the risk of developing symptomatic HF. The literature supports a multi-modality / integrative evaluation of congestion, combining clinical examination, laboratory results and ultrasound evaluation.
The main objective of the CHF-COVReduced study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with reduced left ventricular ejection fraction that are associated with the risk of all-cause death, hospitalization for acute HF or IV diuretics injection in a day hospital.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Reduced Ventricular Ejection Fraction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Clinical examination centered on congestion
Intervention Description
Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
Intervention Type
Procedure
Intervention Name(s)
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds
Intervention Description
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds are optional
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 during day hospitalization or consultation
Intervention Type
Other
Intervention Name(s)
Telephone follow-up
Intervention Description
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
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 death from all causes
Description
composite endpoint : rate of death from all causes, hospitalisation 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
24 months after day hospitalization or consultation
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint : rate of death from all causes, hospitalisation 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
24 months after day hospitalization or consultation
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
composite endpoint : rate of death from all causes, hospitalisation 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
24 months after day hospitalization or consultation
Secondary Outcome Measure Information:
Title
Rate of death from all causes
Description
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)
Time Frame
24 months after day hospitalization or consultation
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4)
Time Frame
24 months after day hospitalization or consultation
Title
Rate of death from all causes
Time Frame
24 months after day hospitalization or consultation
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 8)
Time Frame
24 months after day hospitalization or consultation
Title
Rate of day-hospital or in-home IV diuretics injection for acute HF
Description
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 7)
Time Frame
24 months after day hospitalization or consultation
Title
Rate of hospitalisation for cardiovascular reason
Time Frame
24 months after day hospitalization or consultation
Title
Rate of death from all causes
Description
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 11)
Time Frame
3, 12 and 24 months after day hospitalization or consulation
Title
Rate of hospitalisation for acute heart failure
Description
composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after day hospitalization (with outcome 10)
Time Frame
24 months after day hospitalization or consultation
Title
Rate of cardiovascular death
Time Frame
24 months after day hospitalization or consultation
Title
NYHA (New York Heart Association) class measured
Time Frame
3, 12 and 24 months after day hospitalization or consultation
Title
Natriuretic peptides
Description
BNP or Nt-Pro BNP
Time Frame
At inclusion
Title
Renal function
Description
Assessed by glomerular filtration rate
Time Frame
At inclusion
Title
Plasma volume
Description
calculated from haemoglobin and haematocrit value
Time Frame
At inclusion
Title
Rate of Bilirubin
Time Frame
At inclusion
Title
Rate of ASAT
Time Frame
At inclusion
Title
Rate of ALAT
Time Frame
At inclusion
Title
Rate of V factor
Time Frame
At inclusion
Title
Blood potassium concentration
Time Frame
At inclusion
Title
Circulating NtProBNP
Time Frame
At inclusion
Title
Liver elastography value
Description
Measured with Fibroscan®
Time Frame
At inclusion
Title
Quality of life 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 with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
Patient with altered (left ventricular ejection fraction <40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
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
0033383157322
Ext
+33
Email
n.girerd@chru-nancy.fr
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
Plan to Share IPD
No
Learn more about this trial
CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
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