Evaluating congestion in chronic heart failure with preserved ejection fraction
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)
This study is testing different ways to check for fluid buildup in patients with chronic heart failure who have normal heart function to see how it affects their health and hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT05097898 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with chronic heart failure who have preserved left ventricular ejection fraction. It aims to identify various congestion markers through a combination of clinical examinations, laboratory tests, and ultrasound evaluations. The study will monitor patients during a scheduled hospitalization or consultation, assessing their risk of all-cause death, hospitalization for acute heart failure, or the need for intravenous diuretics. By integrating multiple modalities, the study seeks to improve the understanding and management of congestion in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic heart failure and preserved ejection fraction who are admitted for scheduled consultations or day hospitalization.
Not a fit: Patients with severe comorbidities, those on dialysis, or with significant pulmonary pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better risk stratification and management strategies for patients with chronic heart failure.
How similar studies have performed: Other studies have shown promise in using multi-modality evaluations for heart failure management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vandœuvre-lès-Nancy
- CHRU de Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Study coordinator: Nicolas GIRERD, MD, PhD
- Email: n.girerd@chru-nancy.fr
- Phone: + 33 3 83 15 73 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.