Efficacy of Early Rhythm Control in AF With TR Patients (TRAF)
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ju Youn Kim, Ph.D
- 電話番号：82+ 10-5482-7307
- メール：kzzoo921@gmail.com
研究場所
-
-
Seoul
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Seoul、Seoul、韓国、06351
- 募集
- Samsung Medical Center
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コンタクト：
- Ju Youn Kim, Ph.D
- 電話番号：82+ 2-3410-3419
- メール：kzzoo921@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
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.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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
|
flecainide, propafenone, pilsicainide, sotalol, amiodarone, dronedarone
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.
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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
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General management without atrial fibrillation rhythm control treatment.(Observation
without additional medication, or heart rate control treatment if necessary)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery
時間枠：From January 1, 2013 to December 31, 2023
|
The incidence rate of the major clinical events Major clinical event is;
|
From January 1, 2013 to December 31, 2023
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
All cause death
時間枠：From January 1, 2013 to December 31, 2023
|
The incidence rate of all-cause death during the observation period.
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From January 1, 2013 to December 31, 2023
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Cardiac death
時間枠：From January 1, 2013 to December 31, 2023
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The incidence rate of cardiac death during the observation period.
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From January 1, 2013 to December 31, 2023
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Hospitalization for heart failure
時間枠：From January 1, 2013 to December 31, 2023
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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)
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From January 1, 2013 to December 31, 2023
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Stroke
時間枠：From January 1, 2013 to December 31, 2023
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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)
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From January 1, 2013 to December 31, 2023
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Tricuspid valve surgery
時間枠：From January 1, 2013 to December 31, 2023
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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)
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From January 1, 2013 to December 31, 2023
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Pacemaker implantation
時間枠：From January 1, 2013 to December 31, 2023
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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)
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From January 1, 2013 to December 31, 2023
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SMC 2025-05-075-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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