Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Cardiorenal Syndrome: Characteristics and Prognostic Impact in Advanced Heart Failure (CARAVEL)

29 juin 2026 mis à jour par: Hospices Civils de Lyon

Advanced heart failure (AHF) represents the end stage of chronic heart failure with reduced ejection fraction and affects up to 10% of patients with heart failure. These patients have refractory disease despite optimal guideline-directed medical therapy, and their management is discussed within a multidisciplinary "Heart Team".

Renal dysfunction is highly prevalent in this population. The coexistence of cardiac and renal dysfunction has been classified under the entity of cardiorenal syndrome. Impaired renal function is an independent predictor of adverse cardiovascular and renal outcomes, including death, heart failure decompensation, worsening renal function, and the need for renal replacement therapy. However, patients with AHF remain a particularly complex population, and the lack of longitudinal biological data and limited understanding of the dynamics of cardiorenal syndrome in relation to therapeutic interventions make prognosis assessment and individualized management challenging.

In addition, little is known about renal tubular function in AHF, despite its central role in hydro-electrolytic balance regulation. Biomarkers of tubular injury such as neutrophil gelatinase-associated lipocalin (NGAL) and kidney injury molecule-1 (KIM-1) have shown prognostic value in therapeutic studies, but their relationship with cardiac function and outcomes in advanced heart failure remains insufficiently characterized.

The primary objective of this study is to evaluate renal function parameters and their evolution over time through measurement of glomerular filtration rate (GFR) and assessment of tubular function in patients with advanced heart failure, and to investigate their association with major adverse cardiovascular events.

This is a prospective, single-center RIPH2 cohort study including 100 patients aged 18 to 75 years managed for advanced heart failure at the Louis Pradel Cardiovascular Hospital (Hospices Civils de Lyon, France). Patients will be followed according to standard care at 6, 12, 18, and 24 months. More comprehensive nephrological and cardiological evaluations will be performed at baseline, 12 months, and 24 months. Biobanking and quality-of-life questionnaires will also be conducted during these visits. Blood and urine samples will be collected at baseline and 12 months for NGAL et KIM-1 analysis. In addition, a subgroup of 50 consenting patients without contraindications will undergo multiparametric non-contrast renal MRI combined with tissue sodium quantification using 23Na MRI of the leg.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • France
    • Rhone
      • Bron, Rhone, France, 69500
        • Hospices Civils de Lyon
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Written informed consent signed by the patient,
  • Age ≥ 18 years and ≤ 75 years,

  • Patient with advanced heart failure confirmed by criteria of severe cardiac dysfunction documented in a stable condition, with at least one of the following parameters at baseline:

    • LVEF ≤ 35%,
    • Elevated BNP or NT-proBNP levels (>200 ng/L for BNP and >1000 ng/L for NT-proBNP),
  • NYHA class ≥ 3,
  • At least one hospitalization for heart failure decompensation within the past 24 months,
  • Optimized medical treatment for heart failure according to French/European cardiology guidelines at the maximum tolerated dose for >30 days.

Exclusion Criteria:

  • Presence of severe extracardiac disease with a life expectancy < 1 year,
  • Patient with end-stage renal disease (GFR <15 mL/min/1.73 m²) or on dialysis,
  • History of heart, kidney, or other solid organ transplantation,
  • Patient in cardiogenic shock,
  • INTERMACS profile ≤ 3,
  • Pregnant, parturient, or breastfeeding women*,
  • Individuals deprived of liberty by judicial or administrative decision,
  • Individuals under psychiatric care,
  • Individuals admitted to a health or social institution for purposes other than research,
  • Adults under legal protection (guardianship or curatorship),
  • Individuals not affiliated with a social security system or equivalent coverage.
  • Contraindication to multiparametric renal MRI combined with tissue sodium measurement using non-contrast 23Na MRI of the leg (including inability to undergo MRI as judged by the investigator).

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Patients with cardiorenal syndrome
Patients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care.
Autre: Cardiorenal syndrome follow-up
Patients with cardiorenal syndrome will be followed for 2 years in nephrology and cardiology according to standard of care. In addition, as part of the research, they will complete quality-of-life questionnaires and provide blood, urine, and stool samples for testing and biobanking. An MRI will also be performed for patients participating in the ancillary study.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Occurrence of major cardiovascular events during the first 24 months
Délai: At 12 and 24 months

The primary endpoint of this study is the occurrence of major cardiovascular events during the first 24 months: all-cause mortality, heart transplantation, implantation of a ventricular assist device, hospitalization for heart failure, or worsening ambulatory heart failure.

The association between baseline renal function parameters (GFR, NGA, and KIM-1) and the occurrence of events during the first 24 months will be evaluated, as well as the association between renal function parameters at 12 months and the occurrence of major cardiovascular events between 12 and 24 months.
At 12 and 24 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Blood and urinary levels of NGAL and KIM-1
Délai: at baseline and at 12 months
Blood and urinary measurement of NGAL (neutrophil gelatinase-associated lipocalin) and KIM-1 (kidney injury molecule-1),
at baseline and at 12 months
Occurrence of major adverse renal events
Délai: at baseline, 12 and 24 months

Occurrence of major adverse renal events during the first 24 months: persistent (>30 days) decline in glomerular filtration rate of >40%, initiation of renal replacement therapy, or death due to renal causes.

The association between baseline GFR and the occurrence of adverse renal events during the first 24 months will be evaluated, as well as the association between changes in GFR between baseline and 12 months and the occurrence of adverse renal events between 12 and 24 months.

Occurrence of major adverse renal events during the first 24 months: persistent (>30 days) decline in glomerular filtration rate of >40%, initiation of renal replacement therapy, or death due to renal causes.

The association between baseline GFR and the occurrence of adverse renal events during the first 24 months will be evaluated, as well as the association between changes in GFR between baseline and 12 months and the occurrence of adverse renal events between 12 and 24 months.
at baseline, 12 and 24 months
Occurrence of heart failure decompensation events
Délai: at baseline, 12 and 24 months
Occurrence of heart failure decompensation events (hospitalization, ventricular assist device implantation, or outpatient worsening) during the first 24 months. The association between specific biomarkers of renal tubular injury (serum and urinary NGAL and KIM-1) at baseline and heart failure decompensation events during the first 24 months will be analysed, as well as the association between changes in specific biomarkers of renal tubular injury between baseline and 12 months and the occurrence of heart failure decompensation events between 12 and 24 months.
at baseline, 12 and 24 months
Clinical data collected over a 24-month follow-up period
Délai: over 24 months
Description of the study population over 24 months of follow-up (clinical, paraclinical, therapeutic characteristics, and serious adverse events),
over 24 months
Score of KCCQ questionnaire
Délai: at baseline, and at 6, 12, 18, and 24 months
Each item of KCCQ questionnaire is scored on a 5-point Likert scale and transformed to a 0-100 scale, with higher scores indicating better health status.
at baseline, and at 6, 12, 18, and 24 months
Biomarkers identification
Délai: At baseline, 12 months and 24 months
IBiomarkers identification in biological samples collected in the study biocollection.
At baseline, 12 months and 24 months
Multiparametric renal MRI
Délai: at baseline and at 12 months
Multiparametric renal MRI (BOLD, diffusion, T1 and T2 mapping) in a subgroup of 50 voluntary patients (optional examination)
at baseline and at 12 months
Tissue sodium measurement
Délai: at baseline and at 12 months.
Tissue sodium measurement using 23Na MRI of the leg in a subgroup of 50 voluntary patients (optional examination)
at baseline and at 12 months.
Score of Morisky self-questionnaire MMAS-4
Délai: at baseline, and at 6, 12, 18, and 24 months,
Morisky self-questionnaire MMAS-4 is a generic patient-reported questionnaire used to assess medication adherence. The scale consists of four items, each scored as 0 for "Yes" and 1 for "No". The item scores are summed to yield a total score ranging from 0 to 4. Higher scores indicate better medication adherence.
at baseline, and at 6, 12, 18, and 24 months,

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hospices Civils de Lyon

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

15 novembre 2031

Achèvement de l'étude (Estimé)

15 novembre 2031

Dates d'inscription aux études

Première soumission

4 juin 2026

Première soumission répondant aux critères de contrôle qualité

22 juin 2026

Première publication (Réel)

24 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

1 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 69HCL20_0968

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner