Chronic Heart Failure, Preserved Ejection Fraction
Conditions
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 Preserved study is to identify congestion markers (clinical, biological and ultrasound) quantified during a consultation or day hospitalization for the monitoring of chronic HF with preserved 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.
Interventions
Clinical examination centered on congestion (including the EVEREST, Ambrosy and ASCEND score) will be performed during day hospitalization or consultation
PROCEDURECardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography
Cardiac, vena cava, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography will be performed during day hospitalization or consultation/ peritoneal, jugular and renal Doppler ultrasounds and liver elastography are optional/Cardiac echo is optional for patients included in consultation
PROCEDUREBlood and urine sample retrieved for biological assessment and biobanking
Blood sample retrieved for biological assessment and biobanking will be performed during day hospitalization or consultation/ Urine analysis is optional for patients included in consultation
OTHERTelephone follow-up
Telephone follow-up will be performed 3, 12 and 24
Questionnaire centered on patient's quality of life at discharge and 3, 12 and 24 months after discharge
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic acute heart failure with preserved ejection fraction admitted in hospital for scheduled day hospitalization or consultation * Patient with preserved left ventricular ejection fraction (≥50%). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of death from all causes | 24 months after inclusion | 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 inclusion (with outcome 2 and 3) |
| Rate of hospitalisation for acute heart failure | 24 months after inclusion | 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 inclusion (with outcome 1 and 3) |
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 24 months after inclusion | 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 inclusion (with outcome 1 and 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of day-hospital or in-home IV diuretics injection for acute HF | 24 months after inclusion | composite endpoint: Rate of hospitalisation for acute heart failure or day-hospital/in-home IV diuretics injection for acute HF 24 months after inclusion (with outcome 8) |
| Rate of hospitalisation for cardiovascular reason | 24 months after inclusion | — |
| Rate of cardiovascular death | 24 months after inclusion | — |
| NYHA (New York Heart Association) class measured | 3, 12 and 24 months after inclusion | — |
| Natriuretic peptides | At baseline | BNP or Nt-Pro BNP |
| Renal function | At baseline | Assessed by glomerular filtration rate |
| Plasma volume | At baseline | Calculated from haemoglobin and haematocrit value |
| Number of B-lines measured in lung echography | At baseline | — |
| Rate of ASAT | At baseline | — |
| Rate of ALAT | At baseline | — |
| Rate of V factor | At baseline | — |
| Blood potassium concentration | At baseline | — |
| Liver elastography value | At inclusion | Measured with Fibroscan® |
| Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) | At inclusion and 3, 6 and 24 months | — |
| Rate of bilirubin | At baseline | — |
| Rate of death from all causes | 24 months after inclusion | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 6) |
| Rate of hospitalisation for acute heart failure | 24 months after inclusion | composite endpoint : Rate of death from all causes or hospitalisation for acute heart failure 24 months after inclusion (with outcome 5) |
Countries
France
Contacts
Primary ContactNicolas GIRERD, MD, PhD
Backup ContactSanae BOUALI
Outcome results
None listed