Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)
| Registry | NCT05089149, acronym CHF-COV |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 200 (Estimated) |
| Sponsor | Pr. Nicolas GIRERD (Other) |
| Conditions | Chronic Heart Failure |
| Interventions | 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) (Procedure, other, behavioral) |
| Dates | start 2021-12-14, primary completion 2028-12-14 (estimated), completion 2029-06-14 (estimated), first posted 2021-10-22, last updated 2023-06-05 |
| Locations | 2 sites in France |
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All trials for Chronic Heart Failure All trials of Clinical examination centered on congestion All trials of Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
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-COV study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Patients with chronic heart failure coming for scheduled day hospitalization | Experimental | Procedure: Clinical examination centered on congestion; Procedure: Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography; Procedure: Blood sample retrieved for biological assessment and biobanking; Other: Telephone follow-up; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ) | * 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 |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization or consultation * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| CHRU de Nancy | Vandœuvre-lès-Nancy | France | Recruiting |
| CHRU de Nancy | Vandœuvre-lès-Nancy | France | Not yet recruiting |