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Efficacy of Early Rhythm Control in AF With TR Patients (TRAF)

27 mai 2026 mis à jour par: Ju Youn Kim, Samsung Medical Center
Atrial fibrillation is frequently accompanied by tricuspid regurgitation and may contribute to right atrial and tricuspid annular remodeling, leading to progression of tricuspid regurgitation and adverse clinical outcomes. However, whether early rhythm control improves prognosis in patients with atrial fibrillation and tricuspid regurgitation remains unclear. This study will compare early rhythm control with usual care in these patients, using a composite outcome of cardiac death, heart failure admission, stroke, and tricuspid valve surgery.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

Atrial fibrillation and tricuspid regurgitation frequently coexist in clinical practice. Atrial fibrillation may promote right atrial enlargement and tricuspid annular dilatation, which can aggravate functional tricuspid regurgitation over time. Conversely, significant tricuspid regurgitation may further increase right-sided volume overload, worsen atrial remodeling, and contribute to the persistence or progression of atrial fibrillation. This bidirectional relationship may lead to heart failure, thromboembolic events, and an increased need for tricuspid valve intervention.

Although early rhythm control has been shown to improve cardiovascular outcomes in selected patients with atrial fibrillation, its clinical benefit in patients with concomitant tricuspid regurgitation has not been well established. In particular, it remains uncertain whether maintaining sinus rhythm at an early stage can slow the progression of right-sided cardiac remodeling, reduce heart failure events, and improve long-term prognosis in this population.

This study is designed to evaluate the prognostic impact of early rhythm control compared with usual care in patients with atrial fibrillation and tricuspid regurgitation. The primary endpoint will be a composite of cardiac death, heart failure admission, stroke, and tricuspid valve surgery. By comparing these clinically meaningful outcomes between the two treatment strategies, this study aims to clarify whether early rhythm control should be considered as an active therapeutic approach in patients with atrial fibrillation complicated by tricuspid regurgitation.

The study will use retrospectively collected data from patients diagnosed with atrial fibrillation and tricuspid regurgitation between January 1, 2013 and December 31, 2023. Clinical outcomes will be assessed during this observation period.

Type d'étude

Observationnel

Inscription (Estimé)

5800

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

  • Nom: Ju Youn Kim, Ph.D
  • Numéro de téléphone: 82+ 10-5482-7307
  • E-mail: kzzoo921@gmail.com

Lieux d'étude

  • Corée du Sud
    • Seoul
      • Seoul, Seoul, Corée du Sud, 06351
        • Recrutement
        • Samsung Medical Center
        • 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

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

The investigator emulated a sequential target trial comparing early rhythm control with usual care among patients with atrial fibrillation and tricuspid regurgitation, using data from the Korean National Health Insurance Service (K-NHIS) claims database.

The K-NHIS database represents the entire population of Korea. The K-NHIS database covers the total population of Korea. The NHIS database includes information on all individuals in Korea, such as demographics, diagnosis codes based on the International Classification of Diseases, 10th Revision (ICD-10), procedures, prescriptions (coded by ATC codes), utilization of healthcare services, and mortality linked to national statistics. The investigator further linked these data with the National Health Screening Program, which provides biennial standardized health examination results, including laboratory measurements such as serum creatinine and hemoglobin, using anonymized individual identifiers.

La description

Inclusion Criteria:

  • Patients with concomitant atrial fibrillation and tricuspid regurgitation.

Exclusion Criteria:

  • Patients with a history of valvular surgery
  • Patients with congenital heart disease
  • Patients with primary pulmonary hypertension
  • Patients with CIED implantation prior to the diagnosis of tricuspid regurgitation
  • Patients diagnosed with TR only after the initiation of rhythm control therapy for AF

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

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
early rhythm control group
Patients who received rhythm control therapy(include catheter ablation, cardioversion, anti-arrhythmic drugs) within 2 years of new-onset atrial fibrillation
Médicament: Anti-arrhythmic drugs for rhythm control
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
Procédure: DC cardioversion, catheter ablation for rhythm control
Direct-current cardioversion may be performed to acutely restore sinus rhythm, particularly in patients with persistent atrial fibrillation or symptomatic rhythm deterioration. Catheter ablation may be considered as a more definitive rhythm-control strategy to reduce atrial fibrillation burden and maintain sinus rhythm over the long term.
Usual care group
Patients who received usual care include rate control therapy without early rhythm control intervention within 2 years of new-onset atrial fibrillation
Autre: Usual care
General management without atrial fibrillation rhythm control treatment.(Observation without additional medication, or heart rate control treatment if necessary)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery
Délai: From January 1, 2013 to December 31, 2023

The incidence rate of the major clinical events Major clinical event is;

  1. Cardiac death Death attributable to cardiac causes, including heart failure, myocardial infarction, fatal arrhythmia, sudden cardiac death, or other cardiovascular causes.
  2. Hospitalization for heart failure Hospital admission due to worsening signs or symptoms of heart failure requiring medical treatment, including intravenous diuretics, inotropes, vasodilators, or other heart failure-directed therapy.
  3. Stroke A new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging.
  4. Tricuspid valve surgery Surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement.
From January 1, 2013 to December 31, 2023

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
All cause death
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of all-cause death during the observation period.
From January 1, 2013 to December 31, 2023
Cardiac death
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of cardiac death during the observation period.
From January 1, 2013 to December 31, 2023
Hospitalization for heart failure
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of hospitalization for heart failure during the observation period. (admission due to worsening signs or symptoms of heart failure requiring medical treatment, including intravenous diuretics, inotropes, vasodilators, or other heart failure-directed therapy)
From January 1, 2013 to December 31, 2023
Stroke
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of stroke during the observation period. (new neurological deficit of presumed vascular origin, including ischemic or hemorrhagic stroke, confirmed by clinical evaluation and/or brain imaging)
From January 1, 2013 to December 31, 2023
Tricuspid valve surgery
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of tricuspid valve surgery during the observation period. (surgical or transcatheter intervention for tricuspid valve disease, including tricuspid valve repair or replacement)
From January 1, 2013 to December 31, 2023
Pacemaker implantation
Délai: From January 1, 2013 to December 31, 2023
The incidence rate of pacemaker implantation during the observation period. (new implantation of a permanent pacemaker during the observation period, including single-chamber or dual-chamber pacemaker implantation, when performed for clinically indicated bradyarrhythmia or conduction disease)
From January 1, 2013 to December 31, 2023

Collaborateurs et enquêteurs

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

Parrainer

Samsung Medical Center

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 (Réel)

18 février 2026

Achèvement primaire (Estimé)

28 février 2027

Achèvement de l'étude (Estimé)

28 février 2027

Dates d'inscription aux études

Première soumission

19 mai 2026

Première soumission répondant aux critères de contrôle qualité

19 mai 2026

Première publication (Réel)

26 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

29 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SMC 2025-05-075-1

Plan pour les données individuelles des participants (IPD)

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

NON

Description du régime IPD

Individual participant data will not be shared because this study uses de-identified claims data from the Korean National Health Insurance Service (K-NHIS) database. The investigators are not permitted to provide or redistribute participant-level data under K-NHIS data use policies and privacy regulations.

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

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