CHF-COV: Chronic Heart Failure - COngestion eValuation
Study Details
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-COV study is to identify congestion markers (clinical, biological and ultrasound) in day hospitalization for chronic HF monitoring that are associated with the risk of all-cause death or hospitalization for acute HF within 24 months after day hospitalization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients with chronic heart failure coming for scheduled day hospitalization 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 |
Procedure: Clinical examination centered on congestion
Clinical examination (including the EVEREST score) centered on congestion will be performed during the day hospitalization
Procedure: Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds
Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed during day hospitalization/ peritoneal, jugular and renal venous Doppler ultrasounds 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
Other: Telephone follow-up
Telephone follow-up will be performed 3, 12 and 24 months after day hospitalization
|
Outcome Measures
Primary Outcome Measures
- Rate of death from all causes [24 months after day hospitalization]
composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 2)
- Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
composite endpoint : rate of death from all causes or hospitalisation for acute heart failure during 24 months following day hospitalization (with outcome 1)
Secondary Outcome Measures
- Rate of death from all causes [24 months after day hospitalization]
- Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
- Rate of hospitalisation for cardiovascular reason [24 months after day hospitalization]
- Rate of death from all causes [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 7)
- Rate of hospitalisation for acute heart failure [24 months after day hospitalization]
composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after day hospitalization (with outcome 6)
- Rate of cardiovascular death [24 months after day hospitalization]
- NYHA (New York Heart Association) class measured [3, 12 and 24 months after day hospitalization]
- Natriuretic peptides [24 months after day hospitalization]
BNP or Nt-Pro BNP
- Renal function assessed by glomerular filtration rate [24 months after day hospitalization]
- Plasma volume [24 months after day hospitalization]
Calculated from haemoglobin and haematocrit value
- Rate of Bilirubin [24 months after day hospitalization]
- Rate of ASAT [24 months after day hospitalization]
- Rate of ALAT [24 months after day hospitalization]
- Rate of V factor [24 months after day hospitalization]
- Blood potassium concentration [24 months after day hospitalization]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with chronic acute heart failure admitted in hospital for scheduled day hospitalization
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU de Nancy | Vandoeuvre Les Nancy | France | 54500 | |
| 2 | CHRU de Nancy | Vandœuvre-lès-Nancy | France | 54500 |
Sponsors and Collaborators
- Pr. Nicolas GIRERD
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020PI145-1
- 2020-A02438-31