Renal Artery Denervation in Chronic Heart Failure Study (REACH)
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
調査の概要
詳細な説明
Interventional study
Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation.
Primary Purpose: Treatment
Chronic Systolic Heart Failure
Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System
-Intervention: Device: Renal denervation (Symplicity Catheter System)
Patients are randomised in the cath lab to receive either renal denervation or sham procedure.
Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure)
In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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London、イギリス、W2 1LA
- Imperial College London
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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:
- Chronic heart failure due to systolic dysfunction
- New York Heart Association class II or higher
- Maximal pharmacological therapy including (where clinically indicated and tolerated), b-blocker, ACE inhibitors /A2 blocker, Aldosterone blockade.
- Ejection fraction less than 40%
Exclusion Criteria:
- Estimated GFR<35ml/hr
- Unfavourable renal anatomy (renal artery stenosis)
- Unable to walk on a treadmill for cardiopulmonary exercise test
- Significant valvular disease (moderate or more aortic regurgitation/stenosis or mitral stenosis; severe mitral/tricuspid regurgitation)
- Severe lung disease
- Symptomatic orthostatic dizziness
- Unable to consent
- Pregnancy
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Renal Denervation
Subjects are treated with renal denervation after randomisation and maintained on heart failure medications
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Symplicity Catheter System
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介入なし：Control group
Subject will have a sham procedure and not receive renal denervation.
They will continue with the heart failure medications
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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 |
|---|---|---|
|
Improvement in symptomatology
時間枠：Baseline to 12 months post-randomization
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Improvement in symptomatology assessed using Kansas City Cardiomyopathy Questionnaire
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Baseline to 12 months post-randomization
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Improvement in peak VO2 on cardiopulmonary exercise testing
時間枠：Baseline to 12 months post-randomization
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The peak VO2 will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
|
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Improvement in self-paced exercise distance
時間枠：Baseline to 12 months post-randomization
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Improvement in 6 min walk to in interventional arm compared to sham arm
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Baseline to 12 months post-randomization
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Change in chemoreflex sensitivity
時間枠：Baseline to 12 months post-randomization
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Assess the change in chemoreflex sensitivity in the interventional arm in comparison to the sham arm
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Baseline to 12 months post-randomization
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Change in NYHA functional classification
時間枠：Baseline to 12 months post-randomization
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Assess the change in NYHA in interventional arm in comparison to sham arm
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Baseline to 12 months post-randomization
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Incidence of Major Adverse Events
時間枠：Baseline to 12 months post-randomization
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The incidence of major adverse events will be compared in the interventional against the sham arm
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Baseline to 12 months post-randomization
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Darrel P Francis, BA, MD、Imperial College London
- 主任研究者：Justin E Davies, MBBS, PHD、Imperial College London
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。