CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)
NCT ID: NCT05089162
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2021-12-14
2029-06-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Chronic Heart Failure - COngestion eValuation
NCT05089149
Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation
NCT05097898
Cohort of Heart Failure Patients
NCT03422991
Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation
NCT04343443
Community Surveillance of Congestive Heart Failure
NCT00005517
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with chronic HF with reduced ventricular ejection fraction coming for scheduled day
Clinical examination centered on congestion
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
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
Blood sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clinical examination centered on congestion
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
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
Blood sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation
Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization or consultation
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pr. Nicolas GIRERD
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pr. Nicolas GIRERD
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHRU de Nancy
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020PI145-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.