Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. (H2-FA)
Inhaled Hydrogen Therapy's Effect on Early Recurrences of Atrial Fibrillation Post-ablation. Phase II, Multicenter, Randomized, Controlled, Open-label Clinical Trial
The goal of this clinical trial is to testing the perioperative inhaled hydrogen (H2) administration's effects during atrial fibrillation ablations (AF) to reduce both early and late recurrences associated with this procedure.
Researchers will compare H2 inhalation to the standard of care to see if we observe a reduction in AF recurrence after ablation but also a reduction in rehospitalizations or emergency visits for cardioversion, and consequently an improvement in quality of life.
Participants will:
- have an AF ablation associated to an hydrogen therapy or standard of care
- complete quality of life questionnaires
- record ECG on KardiaMobile©
- Keep a diary of their symptoms
- have a blood test
- have 2 follow-up visits (after 3 and 12 months) and 2 phone calls (after 6 and 9 months)
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Alexandra BIETTE
- 電話番号：0456589886
- メール：ABiette@chu-grenoble.fr
研究連絡先のバックアップ
- 名前：Isabelle BOUDRY
- 電話番号：04 76 76 66 45
- メール：IBoudry@chu-grenoble.fr
研究場所
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Isère
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Grenoble、Isère、フランス、38000
- Chu Grenoble Alpes
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主任研究者：
- Pascal DEFAYE, Pr
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コンタクト：
- Pr Pascal DEFAYE
- 電話番号：0476766823
- メール：PDefaye@chu-grenoble.fr
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コンタクト：
- Sarah LIMON
- 電話番号：0476766823
- メール：Slimon@chu-grenoble.fr
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副調査官：
- Sandrine VENIER, Dr
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副調査官：
- Peggy JACON, Dr
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副調査官：
- Adrien CARABELLI, Dr
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Rhone
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Bron、Rhone、フランス、69500
- Hopital Louis Pradel
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コンタクト：
- Pr Philippe CHEVALIER
- 電話番号：0472357565
- メール：philippe.chevalier@chu-lyon.fr
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コンタクト：
- Carine AKNINE
- 電話番号：0427857747
- メール：carine.aknine@chu-lyon.fr
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主任研究者：
- Philippe CHEVALIER, Pr
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副調査官：
- Kevin GARDEY, Dr
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Be over 18 years old
- Present with paroxysmal or persistent Atrial Fibrilation (AF) of less than 6 months with symptoms
- Be a candidate for a first-time AF ablation (cryoablation and electroporation)
- Understand and agree to comply with the study procedures
- Patient must have a smartphone
- Be enrolled in a social security scheme, or have equivalent rights
- Have signed the study consent form
Exclusion Criteria:
- Being over 80 years old
- Having a left atrial diameter ≥ 50mm on transthoracic echocardiography
- Radiofrequency ablation
- Having a history of AF ablation
- Patient on long-term anti-inflammatory treatment
- Patient with gas administration equipment (CPAP, NIV…)
- Woman of childbearing potential*
- Non-cooperative patient
- In the exclusion period for another study
- Persons covered by Articles L1121-5 to L1121-8 of the Public Health Code and Articles 31 to 35 of Regulation 536/2014 (corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8, persons admitted to a healthcare or social facility for purposes other than research, minors, persons subject to legal protection measures or unable to give their consent).
- Staff with a hierarchical relationship with the principal investigator
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Standard of care
patients treated with usual care (Standard of Care) |
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実験的：H2
patient treated with inhaled hydrogen therapy during the perioperative period |
Patients treated with inhaled hydrogen therapy in the perioperative period (initiation of inhaled hydrogen therapy from hospital admission until discharge, except in the operating room) (dosage : H2/N2 3.6%/96.4%, 1 L/min 24 hours a day)
他の名前：
|
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 |
|---|---|---|
|
Effectiveness of inhaled hydrogen therapy on early recurrences of atrial fibrillation post-ablation and on the improvement of quality of life at 3 months
時間枠：From baseline (before ablation) to 3 months after ablation
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Composite binary endpoint, reported as the number of participants meeting both criteria: (1) no early recurrence during the blanking period (first 3 months after ablation), where recurrence is defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds; AND (2) improvement in quality of life, defined as an improvement in quality of life, defined as an increase of at least 5 points in the AFEQT overall score (range 0-100; higher scores indicate better quality of life) between baseline and 3 months. |
From baseline (before ablation) to 3 months after ablation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of hospitalizations or electrical cardioversions or pharmacological cardioversions during the blanking period (3 months)
時間枠：From ablation to 3 months after ablation
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Total number of hospitalizations or electrical cardioversions or pharmacological cardioversions occurring during the blanking period, i.e. the first 3 months after ablation. The three event types are summed into a single count per participant. |
From ablation to 3 months after ablation
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Incidence of Late Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia Recurrence Between 3 and 12 Months After Ablation
時間枠：From 3 months to 12 months after ablation
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Number of participants with late recurrence, defined as any episode of atrial fibrillation, atrial flutter or atrial tachycardia lasting at least 30 seconds on Holter or Kardia recording, or recorded on a 12-lead electrocardiogram, occurring more than 3 months and up to 12 months after ablation. |
From 3 months to 12 months after ablation
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|
Change in White Blood Cell Count (WBC) from before ablation to 24 and 48 hours after ablation
時間枠：24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Change in blood white blood cell (WBC) count, measured in 10^9 cells/L, between 24 hours before ablation and 24 hours and 48 hours after ablation. |
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Change in High-Sensitivity C-Reactive Protein (CRP) from before ablation to 24 and 48 hours after Ablation
時間枠：24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Change in blood high-sensitivity C-reactive protein (hs-CRP) concentration, measured in mg/L, between 24 hours before ablation and 24 hours and 48 hours after ablation. |
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Change in Interleukin-6 from before ablation to 24 and 48 hours after Ablation
時間枠：24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Change in blood interleukin-6 (IL-6) concentration, measured in pg/mL, between 24 hours before ablation and 24 hours and 48 hours after ablation. |
24 hours before ablation, 24 hours after ablation, and 48 hours after ablation
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Incidence of Adverse Events Graded by NCI-CTCAE Version 5.0 (Safety and Tolerability)
時間枠：From the start of inhaled hydrogen therapy to 12 months after ablation
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Number of participants with adverse events, described and graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grades range from 1 (mild) to 5 (death related to adverse event); higher grades indicate more severe events. |
From the start of inhaled hydrogen therapy to 12 months after ablation
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Evaluate the acceptability of hydrogen therapy treatment by healthcare providers
時間枠：Day 2 after ablation
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Custom hetero-questionnaire on the acceptability of hydrogen therapy treatment by healthcare providers |
Day 2 after ablation
|
協力者と研究者
捜査官
- 主任研究者：Pascal DEFAYE, Pr、CHU Grenoble Alpes
研究記録日
主要日程の研究
研究開始 (推定)
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
その他の研究ID番号
- 38RC22.0404
- 2024-520131-33-00 (Ctis)
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
米国で製造され、米国から輸出された製品。
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