Chronic Heart Failure - COngestion eValuation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Chronic Heart Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique. CHF-COV (Chronic Heart Failure - COngestion eValuation)
Overview
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.
Interventions
- Procedure Clinical examination centered on congestion
Clinical examination (including the EVEREST, ASCEND and Ambrosy scores) centered on congestion will be performed during day hospitalization or consultation - Procedure Cardiac, pulmonary, peritoneal, jugular, renal Doppler ultrasounds and liver elastography
Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional - Procedure Blood sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation - Other Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after visit (during day hospitalization or consultation) - Behavioral Kansas City Cardiomyopathy Questionnaire (KCCQ)
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Primary outcome measures
- Rate of death from all causes [Time frame: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Time frame: 24 months after day hospitalization or consultation]
Secondary outcome measures (12)
- Rate of death from all causes [Time frame: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Time frame: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for cardiovascular reason [Time frame: 24 months after day hospitalization or consultation]
- Rate of death from all causes [Time frame: 24 months after day hospitalization or consultation]
- Rate of hospitalisation for acute heart failure [Time frame: 24 months after day hospitalization or consultation]
- Rate of cardiovascular death [Time frame: 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 consulation]
- Natriuretic peptides [Time frame: At inclusion]
- Renal function assessed by glomerular filtration rate [Time frame: At inclusion]
- Plasma volume [Time frame: At inclusion]
- Rate of Bilirubin [Time frame: At inclusion]
- Rate of ASAT [Time frame: At inclusion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- CHRU de Nancy — Vandœuvre-lès-Nancy
- CHRU de Nancy — Vandœuvre-lès-Nancy
Identifiers
NCT: NCT05089149 · 2020PI145-1 · 2020-A02438-31