Clinical trial NCT05097898: Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation
Official title: Évaluation de la Congestion en Ambulatoire Chez Les Patients Atteints d'Insuffisance Cardiaque Chronique à Fraction d'éjection préservée. CHF-COV Preserved (Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Preserved Ejection Fraction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of death from all causes
timeFrame: 24 months after inclusion
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after inclusion
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 24 months after inclusion
Secondary outcomes:
measure: Number of B-lines measured in lung echography
timeFrame: At baseline
measure: Rate of death from all causes
timeFrame: 24 months after inclusion
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after inclusion
measure: Rate of death from all causes
timeFrame: 24 months after inclusion
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after day hospitalization
measure: Rate of day-hospital or in-home IV diuretics injection for acute HF
timeFrame: 24 months after inclusion
measure: Rate of hospitalisation for cardiovascular reason
timeFrame: 24 months after inclusion
measure: Rate of death from all causes
timeFrame: 24 months after inclusion
measure: Rate of hospitalisation for acute heart failure
timeFrame: 24 months after inclusion
measure: Rate of cardiovascular death
timeFrame: 24 months after inclusion
measure: NYHA (New York Heart Association) class measured
timeFrame: 3, 12 and 24 months after inclusion
measure: Natriuretic peptides
timeFrame: At baseline
measure: Renal function
timeFrame: At baseline
measure: Plasma volume
timeFrame: At baseline
measure: Rate of bilirubin
timeFrame: At baseline
measure: Rate of ASAT
timeFrame: At baseline
measure: Rate of ALAT
timeFrame: At baseline
measure: Rate of V factor
timeFrame: At baseline
measure: Blood potassium concentration
timeFrame: At baseline
measure: Liver elastography value
timeFrame: At inclusion
measure: Quality of life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: At inclusion and 3, 6 and 24 months
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: