- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05089162
CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation) (CHF-COVReduced)
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)
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolas GIRERD, MD, PhD
- Phone Number: +33 0033383157322
- Email: n.girerd@chru-nancy.fr
Study Locations
-
-
-
Vandoeuvre Les Nancy, France, 54500
- Recruiting
- CHRU de Nancy
-
Contact:
- Nicolas GIRERD, MD, PhD
- Phone Number: +333 +33383157322
- Email: n.girerd@chru-nancy.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
|
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Clinical examination centered on congestion (including the EVEREST, ASCEND and Ambrosy scores) will be performed during day hospitalization or consultation
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of death from all causes
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
Rate of hospitalisation for acute heart failure
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of death from all causes
Time Frame: 24 months after day hospitalization or consultation
|
24 months after day hospitalization or consultation
|
|
Rate of hospitalisation for cardiovascular reason
Time Frame: 24 months after day hospitalization or consultation
|
24 months after day hospitalization or consultation
|
|
Rate of cardiovascular death
Time Frame: 24 months after day hospitalization or consultation
|
24 months after day hospitalization or consultation
|
|
Natriuretic peptides
Time Frame: At inclusion
|
BNP or Nt-Pro BNP
|
At inclusion
|
Rate of Bilirubin
Time Frame: At inclusion
|
At inclusion
|
|
Rate of ASAT
Time Frame: At inclusion
|
At inclusion
|
|
Rate of ALAT
Time Frame: At inclusion
|
At inclusion
|
|
Rate of V factor
Time Frame: At inclusion
|
At inclusion
|
|
Blood potassium concentration
Time Frame: At inclusion
|
At inclusion
|
|
Liver elastography value
Time Frame: At inclusion
|
Measured with Fibroscan®
|
At inclusion
|
Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: At inclusion and 3, 6 and 24 months
|
At inclusion and 3, 6 and 24 months
|
|
Rate of death from all causes
Time Frame: 24 months after day hospitalization or consultation
|
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 5)
|
24 months after day hospitalization or consultation
|
Rate of hospitalisation for acute heart failure
Time Frame: 24 months after day hospitalization or consultation
|
composite endpoint of rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 4)
|
24 months after day hospitalization or consultation
|
Rate of hospitalisation for acute heart failure
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
Rate of day-hospital or in-home IV diuretics injection for acute HF
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
Rate of death from all causes
Time Frame: 3, 12 and 24 months after day hospitalization or consulation
|
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)
|
3, 12 and 24 months after day hospitalization or consulation
|
Rate of hospitalisation for acute heart failure
Time Frame: 24 months after day hospitalization or consultation
|
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)
|
24 months after day hospitalization or consultation
|
NYHA (New York Heart Association) class measured
Time Frame: 3, 12 and 24 months after day hospitalization or consultation
|
3, 12 and 24 months after day hospitalization or consultation
|
|
Renal function
Time Frame: At inclusion
|
Assessed by glomerular filtration rate
|
At inclusion
|
Plasma volume
Time Frame: At inclusion
|
calculated from haemoglobin and haematocrit value
|
At inclusion
|
Circulating NtProBNP
Time Frame: At inclusion
|
At inclusion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI145-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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