Chronic Heart Failure With Preserved Ejection Fraction - COngestion eValuation (CHF-COV-P)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Preserved Ejection Fraction; Chronic Heart Failure

Treatments: Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography; Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ); Other: Telephone follow-up; Procedure: Clinical examination centered on congestion; Procedure: Blood and urine sample retrieved for biological assessment and biobanking

Study type: Interventional

Funder types: Other

Identifiers

NCT05097898

2020PI145-3

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients with chronic HFpEF coming for scheduled day hospitalization or consultation

Experimental group

Description:

* 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

Treatment:

Procedure: Cardiac, pulmonary, peritoneal, jugular and renal Doppler ultrasounds and liver elastography

Procedure: Blood and urine sample retrieved for biological assessment and biobanking

Other: Telephone follow-up

Behavioral: Kansas City Cardiomyopathy Questionnaire (KCCQ)

Procedure: Clinical examination centered on congestion