Identifying congestion markers in acute heart failure patients
Acute Heart Failure - COngestion Repeated Evaluation (AHF-CORE). Evaluation répétée de la Congestion au Cours d'Une Hospitalisation Pour Insuffisance Cardiaque aigüe
This study is trying to find signs of fluid buildup in patients with acute heart failure to see if these signs can help predict their risk of dying or going back to the hospital within three months after they leave.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 2 sites (Metz, Lorraine and 1 other locations) |
| Trial ID | NCT03327532 on ClinicalTrials.gov |
What this trial studies
The AHF-CORE study aims to identify clinical, biological, and ultrasound markers of congestion in patients hospitalized for acute heart failure. This prospective, non-randomized, multicenter study will evaluate these markers at the beginning and end of hospitalization to determine their association with the risk of death or rehospitalization within three months post-discharge. Patients will undergo routine care while their congestion markers are assessed, and follow-up will be conducted via telephone interviews to collect vital status and rehospitalization data.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old hospitalized for left-sided or global acute heart failure within 72 hours of admission.
Not a fit: Patients with a life expectancy of three months or less due to comorbidities or those with recent heart failure diagnosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the prediction of outcomes for patients with acute heart failure, potentially leading to better management strategies.
How similar studies have performed: Other studies have shown promise in using similar approaches to assess congestion markers in heart failure, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients hospitalized for left-sided or global acute heart failure due to exacerbation of chronic heart failure within 72 hours of admission to hospital * Patients over 18 years old * Person affiliated to or beneficiary of a social security plan * Person informed about study organization and having signed the informed consent Exclusion Criteria: * Comorbidity for which life expectancy is ≤ 3 months * Diagnosis of heart failure made less than 3 months prior to inclusion * Exacerbation of heart failure attributed to acute ischemic stroke (acute coronary syndrome with or without ST segment elevation) * Dialyzed patient (peritoneal dialysis or hemodialysis) and patients with glomerular filtration rate \<15 ml / min / m2 at baseline * History of pulmonary lobectomy or pneumonectomy * Severe pulmonary or pleural disease preventing the reliable acquisition of pulmonary ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis * Suspected cardiac amylose or proven cardiac amylose * Woman of childbearing age without effective contraception * Persons referred in articles L.1121-5, L.1121-7, L.1121-8 and L.1122-2 of the French Public Health Code: Pregnant, parturient or breastfeeding woman ; Minor person (non-emancipated) ; Adult person under legal protection (any form of public guardianship) ; Adult person incapable of giving consent and not under legal protection. * Persons deprived of liberty for judicial or administrative decision * Persons subject to psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
Where this trial is running
Metz, Lorraine and 1 other locations
- CHR Metz-Thionville - Hôpital de Mercy — Metz, Lorraine, France (Recruiting)
- CHRU Nancy Hôpitaux de Brabois — Vandœuvre-lès-Nancy, Lorraine, France (Recruiting)
Study contacts
- Principal investigator: Nicolas GIRERD, MD,PhD — Centre d'Investigation Clinique 1433 module Plurithématique de Nancy
- Study coordinator: Nicolas GIRERD, MD,PhD
- Email: n.girerd@chru-nancy.fr
- Phone: + 33 3 83 15 74 96
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.