RESynchronisation in Patients With Heart Failure and a Normal QRS Duration (RESPOND)
Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.
We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.
調査の概要
詳細な説明
AIMS and Objectives A randomised controlled clinical trial
Primary objective
• Improvements in 6-min walking distance
Secondary objectives Determine
- Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
- Change in NT pro-BNP and echocardiographic parameters of LV function
- Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.
- Morbidity and Mortality using CARE-HF definitions
- Packer combined clinical composite score
Study Design A pilot randomised controlled clinical trial 60 patients. The biventricular pacemaker with be optimized for both A-V delay and V-V delay.
Subject Selection Source - Patients attending Good Hope Hospital, Sandwell Hospital Centres involved - 2 Eligible Participants - 60 patients with heart failure and narrow QRS.
Inclusion Criteria Sinus rhythm Symptomatic heart failure - NYHA class III or IV ECG QRS duration less than 120 milliseconds LV ejection fraction of less than 35% on echocardiography using Simpsons technique.
Able to give informed consent
Exclusion Criteria Age below 18 Current or planned pregnancy Patient refusal Ventricular tachycardia or ventricular fibrillation Current or recent (within last 30 days) involvement in other studies Requires implantable cardioverter defibrillator (ICD) according to NICE criteria for implantation (England and Wales)
Definition of clinical response:- 20% improvement in 6 minute walk distance or any improvement from 0
Definition of echocardiographic response:- 15% or greater decrease in left ventricular end systolic volume
Follow up 6 weeks and 6 monthly thereafter. Interim results at 6 months. Analysis of results, echocardiograms, MRI and BNP will be blind Walk distance to be measured by unblinded observer and by pedometer.
Randomisation:
Numbered envelopes will be prepared by sponsor (Heart of England NHS Foundation Trust) and kept from researchers. After informed consent, the patient will be enrolled and the technician will draw the result.
This trial was known as the Birmingham biventricular pacing in patients unselected for dyssynchrony (BIPIDS).
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
-
-
-
Birmingham、イギリス、B71 4HJ
- Sandwell Hospital
-
Sutton Coldfield、イギリス、B75 7RR
- Good Hope Hospital
-
-
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:
- Sinus rhythm
- Symptomatic heart failure - NYHA class III or IV
- ECG QRS duration less than 120 milliseconds
- LV ejection fraction of less than 35% on echo
- Able to give informed consent
Exclusion Criteria:
- Age below 18
- Current or planned pregnancy
- Patient refusal
- Ventricular tachycardia or ventricular fibrillation
- Current or recent (within last 30 days) involvement in other studies
- Requires implantable cardioverter defibrillator (ICD)
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：なし（オープンラベル）
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 |
|---|---|
|
Improvements in 6-min walking distance
時間枠：6 months
|
6 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
時間枠：6 months
|
6 months
|
|
Change in NT pro-BNP and echocardiographic parameters of LV function
時間枠：6 months
|
6 months
|
|
Does MRI Dyssynchrony Index (CMR-TSI) predicts responders
時間枠：6 months
|
6 months
|
協力者と研究者
捜査官
- スタディチェア：Francisco Leyva, MD MB BS、University of Birmingham
- 主任研究者：Paul W Foley, MB ChB MRCP、Heart of England NHS Foundation Trust
- 主任研究者：Kiran Patel, PhD MRCP、Sandwell & West Birmingham Hospitals NHS Trust
- 主任研究者：Berthold Stegemann, PhD、Bakken Research Centre, The Netherlands
- 主任研究者：Russell EA Smith, FRCP MD、University Hospital Birmingham
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 (実際)
研究の完了 (実際)
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 (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
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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