Evaluating congestion in chronic heart failure patients

Evaluation de la Congestion en Hospitalisation de Jour Pour un Bilan d'Insuffisance Cardiaque Chronique à Fraction d'éjection altérée ou modérément altérée CHF-COV Reduced (Chronic Heart Failure With Reduced Ejection Fraction - COngestion eValuation)

This study is testing different ways to measure congestion in people with chronic heart failure to see how it relates to their risk of serious health issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (other)
• Locations: 1 site (Vandœuvre-lès-Nancy)
• Trial ID: NCT05089162 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with chronic heart failure and reduced ejection fraction, aiming to identify various congestion markers through clinical examinations, laboratory tests, and ultrasound evaluations. By quantifying these markers during consultations or day hospitalizations, the study seeks to correlate them with the risk of all-cause mortality, hospitalizations for acute heart failure, or the need for intravenous diuretics. The approach is integrative, combining multiple modalities to provide a comprehensive assessment of congestion in these patients.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic heart failure and reduced left ventricular ejection fraction, specifically those with an ejection fraction below 50%.

Not a fit: Patients with severe comorbidities, those on dialysis, or individuals with significant pulmonary conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved monitoring and management strategies for patients with chronic heart failure, potentially reducing hospitalizations and improving patient outcomes.

How similar studies have performed: Other studies have shown promise in using multi-modality evaluations for heart failure management, suggesting that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

* Patients with chronic acute heart failure with reduced ventricular ejection fraction admitted in hospital for scheduled day hospitalization or in consultation
* Patient with altered (left ventricular ejection fraction \<40%) and moderately altered (left ventricular ejection fraction between 40 and 50%) left ventricular ejection fraction
* 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.

Where this trial is running

Vandœuvre-lès-Nancy

• CHRU de Nancy — Vandœuvre-lès-Nancy, France (RECRUITING)

Study contacts

• Study coordinator: Nicolas GIRERD, MD, PhD

Conditions: Chronic Heart Failure, Reduced Ventricular Ejection Fraction