Improving Outcomes After AF Ablation in Obese Patients (OBESE-AF)
Outcome Improvement in Obese Patients With Atrial Fibrillation After Catheter Ablation: Importance of Gut Microbiota Dysbiosis and Adipose Tissue Biology
調査の概要
詳細な説明
This is a prospective randomized clinical study designed to evaluate the roles of gut microbiota dysbiosis, adipose tissue biology, and post-ablation lifestyle intervention in patients with atrial fibrillation undergoing catheter ablation. Patients with paroxysmal or persistent atrial fibrillation who are scheduled to undergo catheter ablation at National Taiwan University Hospital will be enrolled after informed consent.
All participants will undergo standard-of-care catheter ablation and receive guideline-directed management for atrial fibrillation, including treatment of cardiovascular conditions, anticoagulation, and rate or rhythm control as clinically indicated. After the index ablation procedure, participants will be randomly assigned in a 1:1 ratio to either an intensive lifestyle modification program or usual care.
Participants assigned to the intensive lifestyle modification group will receive dietary counseling for weight reduction when indicated and an exercise-based cardiac rehabilitation program. The rehabilitation program will include supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise. Participants assigned to the usual care group will continue their usual lifestyle and receive standard post-ablation clinical follow-up.
The study will collect clinical characteristics, procedural data, rhythm follow-up data, biological samples, and imaging-based measurements. Gut microbiota dysbiosis will be assessed using stool specimens and high-throughput sequencing of the V3 and V4 hypervariable regions of 16S rRNA. Adipose tissue biology will be evaluated using computed tomography to quantify the amount and distribution of adipose tissue, including epicardial, paracardial, pericardial, visceral, and subcutaneous fat. Serum biomarkers related to inflammation and fibrosis, including hs-CRP, TNF-alpha, IL-1 beta, ST2, and galectin-3, will also be assessed.
Cardiac structural remodeling will be evaluated using cardiac computed tomography and echocardiography, including left atrial size, left ventricular mass, left ventricular ejection fraction, and parameters of left ventricular diastolic function. Electrophysiological remodeling of the left atrium will be assessed using three-dimensional voltage mapping during the ablation procedure, including the extent of scar and low-voltage zones.
Participants will undergo rhythm follow-up after catheter ablation using 12-lead electrocardiography, continuous patch electrocardiographic monitoring, and Holter monitoring as clinically indicated. The study will evaluate AF-free survival after the blanking period and will explore whether the post-ablation lifestyle intervention modifies ablation outcomes, body mass index, metabolic parameters, gut microbiota dysbiosis, adipose tissue biology, cardiac structural remodeling, and electrophysiological remodeling.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Yen Bin, Liu Associate Professor of Medicine, MD, PhD
- 電話番号:+886-0972651035
- メール:yenbin@ntu.edu.tw
研究連絡先のバックアップ
- 名前:Chun Kai, Chen Visiting staff, MD
- 電話番号:+886-0921915778
- メール:neochen@ntuh.gov.tw
研究場所
-
-
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Taipei、台湾
- 募集
- National Taiwan University Hospital
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Patients with Class I indication of catheter ablation of paroxysmal or persistent AF and will undergo catheter ablation at National Taiwan University Hospital.
Exclusion Criteria:
- Informed consent could not be obtained due to personal problem
- Unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular
- Current or scheduled enrollment in other conflicting studies, and
- Concomitant disease or other medical condition likely to result in death within 6 months
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Cardiac rehabilitation
Participants assigned to this arm will receive an intensive lifestyle modification program after the index catheter ablation procedure.
The program includes an exercise-based cardiac rehabilitation program with aerobic exercise and resistance or strength training, in addition to standard post-ablation care.
|
The intervention consists an exercise-based cardiac rehabilitation program after catheter ablation.
The rehabilitation program includes supervised aerobic exercise and resistance or strength training, together with recommendations for home-based moderate-intensity walking exercise.
|
|
アクティブコンパレータ:Usual Care
Participants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure.
|
Participants assigned to this arm will continue their usual lifestyle and receive standard post-ablation clinical follow-up after the index catheter ablation procedure.
|
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 |
|---|---|---|
|
Atrial Fibrillation-Free Survival After Catheter Ablation
時間枠:From 3 months after catheter ablation through study follow-up, up to 36 months
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Atrial fibrillation-free survival after the 3-month blanking period following the index catheter ablation procedure.
Rhythm status will be assessed using 12-lead electrocardiography, 7-day continuous patch electrocardiographic monitoring at 6 months, and annual 24-hour Holter monitoring after the index ablation procedure.
|
From 3 months after catheter ablation through study follow-up, up to 36 months
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- 202006062RINC
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?
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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