Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction (REPRIEVED)
REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked.
It is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease.
Researchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent.
350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes.
Before the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart.
On the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment.
Participants will then be contacted by a member of the research team at 3 months and 6 months after their procedure.
At 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit.
At 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart.
Participants will be told whether they received the stent procedure or the placebo procedure.
調査の概要
状態
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究場所
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London、イギリス
- 募集
- Guy's & St Thomas' NHS Foundation Trust
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コンタクト：
- Matthew Ryan
- 電話番号：+442071881041
- メール：matthew.ryan@kcl.ac.uk
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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:
1. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:
- Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and
- Left ventricular ejection fraction ≥ 50% and
- NT-pro-BNP > 125 pg/ml in sinus rhythm or > 365 pg/ml in atrial fibrillation and
- One or more of the following objective signs of left ventricular diastolic dysfunction:
i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure > 35mmHg or tricuspid regurgitation velocity > 2.8 m/s on echocardiography iii. Left atrial volume index > 34ml/m2 in patient in sinus rhythm or left atrial volume index > 40ml/m2 in atrial fibrillation iv. Relative left ventricular wall thickness > 0.42 v. Left ventricular mass index ≥ 95 g/m2 in females or ≥ 115 g/m2 in males vi. Mitral E/E' ratio > 9
Exclusion Criteria:
- Age <18 years
- People without capacity to provide informed consent
- PCI contraindicated or not feasible on coronary angiography or screening CTCA
- Contraindication to clopidogrel/dual antiplatelet therapy
- Recent acute myocardial infarction or coronary revascularisation (within 90 days)
- Enrolment in another interventional study which may affect study outcomes
- Severe chronic obstructive pulmonary disease (GOLD stage ≥3)
- Haemoglobin <=80 g/L
- Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
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 |
|---|---|
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アクティブコンパレータ：PCI
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Participants will receive percutaneous coronary intervention (PCI) as per current standard of care.
Angioplasty and stenting will be attempted to all significant coronary stenoses as determined by the CT-FFR or FFR measurements.
Contemporary best practice including the use of intracoronary imaging is mandated.
The default approach will be to implant drug eluting stents, but drug coated balloon angioplasty is permitted in selected cases in accordance with the current evidence base and guidelines.
Operators will achieve as much revascularisation as can safely be delivered in a timeframe which maintains blinding; if incomplete revascularisation is necessary, operators will target treatment to the most haemodynamically significant lesions subtending the largest territories.
Staged procedures are not permitted.
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プラセボコンパレーター：Placebo PCI
Participants will undergo a placebo stent procedure that involves placement of a catheter but no actual stent.
Participants randomised to the placebo procedure will receive matching placebo clopidogrel capsules, to be taken for up to 6 months after the procedure.
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Participant will undergo a placebo PCI procedure that involves placement of a thin tube to image the blood vessel but does not involve placement of an actual stent.
Movements of the image intensifier, screen display and personnel will simulate a PCI procedure.
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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 |
時間枠 |
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Quality of life measured using KCCQ-OSS
時間枠：At 6 months
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At 6 months
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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 |
|---|---|---|
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All-cause death and hospitalisation for heart failure
時間枠：At 6 months
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At 6 months
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Efficacy of blinding assessed using the blinding index
時間枠：At discharge from the procedure
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The blinding index is scaled to an interval of -1 to 1, 1 being complete lack of blinding, 0 being consistent with perfect blinding and -1 indicating opposite guessing which may be related to unblinding.
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At discharge from the procedure
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Individual components of the KCCQ (including total symptom score and clinical summary score)
時間枠：At 6 months
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At 6 months
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Health status measured using New York Heart Association (NYHA) functional class
時間枠：At 6 months
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At 6 months
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NT-pro-BNP measured using blood test/assay
時間枠：At 6 months
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At 6 months
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Difference in left ventricular ejection fraction (LVEF)
時間枠：At 6 months
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At 6 months
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Difference in diastolic function (mitral E/e')
時間枠：At 6 months
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At 6 months
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協力者と研究者
出版物と役立つリンク
便利なリンク
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
- IRAS ID 330189
- NIHR159715 (その他の助成金/資金番号：National Institute for Health and Care Research)
- 12843546 (レジストリ識別子：ISRCTN)
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
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。
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