Efficacy of Early Rhythm Control in AF With TR Patients (TRAF)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ju Youn Kim, Ph.D
- 전화번호: 82+ 10-5482-7307
- 이메일: kzzoo921@gmail.com
연구 장소
-
-
Seoul
-
Seoul, Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
-
연락하다:
- Ju Youn Kim, Ph.D
- 전화번호: 82+ 2-3410-3419
- 이메일: kzzoo921@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
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.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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.
|
|
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
|
General management without atrial fibrillation rhythm control treatment.(Observation
without additional medication, or heart rate control treatment if necessary)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
A composite of cardiac death, hospitalization for heart failure, stroke, and tricuspid valve surgery
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
All cause death
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SMC 2025-05-075-1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .