ChiCTR-ONRC-10001036 版本V1.1 版本创建时间2015/06/27 12:51:31 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-ONRC-10001036 

最近更新日期：

Date of Last Refreshed on：

 2015-06-27 12:50:54 

注册时间：

Date of Registration：

 2010-07-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變的研究

Public title：

Mechanistic Assessment of Changes in Cardiac Function by Cardiac Contractility Modulation by Multi-modality Echocardiographic Imaging

注册题目简写：

English Acronym：

研究课题的正式科学名称：

對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變的研究

Scientific title：

Mechanistic Assessment of Changes in Cardiac Function by Cardiac Contractility Modulation by Multi-modality Echocardiographic Imaging

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

CUHK_CCT00255

申请注册联系人：

Cheuk Man Yu 

研究负责人：

Cheuk Man Yu 

Applicant：

Cheuk Man Yu 

Study leader：

Cheuk Man Yu 

申请注册联系人电话：

Applicant telephone：

 +852 2632 1752

研究负责人电话：

Study leader's
telephone：

+852 2632 1752

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 poonsp@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 cmyu@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00255

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00255

申请注册联系人通讯地址：

Rm. 104041, 8/F, Chinese University of Hong Kong

研究负责人通讯地址：

Rm. 104041, 8/F, Chinese University of Hong Kong

Applicant address：

Rm. 104041, 8/F, Chinese University of Hong Kong

Study leader's address：

Rm.12A28, 12/F, main building, PWH

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 NA

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Chinese University of Hong Kong

Name of the ethic committee：

Chinese University of Hong Kong

伦理委员会批准日期：

Date of approved by ethic committee：

 2009-03-25 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Chinese University of Hong Kong

Primary sponsor：

Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Chinese University of Hong Kong

Primary sponsor's address：

Rm. 104041, 8/F, Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

RGC funding for the study

Source(s) of funding：

RGC funding for the study

研究疾病：

Heart failure (HF)  

Target disease：

Heart failure (HF)

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變  

Objectives of Study：

To explore mechanistic of Changes in Cardiac Function by Cardiac Contractility Modulation by Multi-modality Echocardiographic Imaging

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1). Heart failure (HF) patients with left ventricular ejection fraction less than or equal to 35% by echocardiography and New York Heart Association Class III or IV 2). Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, β-blockers, etc. 3). QRS duration < 130ms or if QRS >130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians 4). If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled

Inclusion criteria

1). Heart failure (HF) patients with left ventricular ejection fraction less than or equal to 35% by echocardiography and New York Heart Association Class III or IV 2). Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, β-blockers, etc. 3). QRS duration < 130ms or if QRS >130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians 4). If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled

排除标准：

1). Subjects with severe symptomatic HF who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be <11 ml/kg/min
2). Subjects who have a potentially correctible cause of HF, such as valvular heart disease or congenital heart disease.
3). Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
4). Subjects who have been hospitalized for HF which required the use of intravenous diuretics or inotropic support within two weeks of enrollment.
5). Subjects without an implantable cardioverter defibrillator (ICD) who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of CCM.
6). Subjects who have an ICD who have had appropriate ICD firing during the past one month.
7). Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular contractions per 24 hours on baseline Holter monitoring (which reduce significantly reducing the amount of CCM delivery).
8). Subjects who have chronic atrial fibrillation or chronic atrial flutter.
9). Subjects whose exercise tolerance is limited by a condition other than HF (e.g., angina, chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions).
10). Subjects who are unable to participate in a 6-minute hall walk or a cardiopulmonary stress test.
11). Subjects who are scheduled for a coronary revascularization (CABG or PCI) procedure, or who have undergone a CABG procedure within three months or a PCI procedure within one month of enrollment.
12). Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated.
13). Subjects who have had a myocardial infarction within three months of enrollment.
14). Subjects who have mechanical tricuspid or aortic valves.
15). Subjects who have a prior heart transplant.
16). Subjects who have a previously implanted ICD which employs unipolar or integrated bipolar sensing
17). Subjects who are participating in another experimental protocol.
18). Subjects who are unable to provide informed consent.

Exclusion criteria：

1). Subjects with severe symptomatic HF who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be <11 ml/kg/min
2). Subjects who have a potentially correctible cause of HF, such as valvular heart disease or congenital heart disease.
3). Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation.
4). Subjects who have been hospitalized for HF which required the use of intravenous diuretics or inotropic support within two weeks of enrollment.
5). Subjects without an implantable cardioverter defibrillator (ICD) who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of CCM.
6). Subjects who have an ICD who have had appropriate ICD firing during the past one month.
7). Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 premature ventricular contractions per 24 hours on baseline Holter monitoring (which reduce significantly reducing the amount of CCM delivery).
8). Subjects who have chronic atrial fibrillation or chronic atrial flutter.
9). Subjects whose exercise tolerance is limited by a condition other than HF (e.g., angina, chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions).
10). Subjects who are unable to participate in a 6-minute hall walk or a cardiopulmonary stress test.
11). Subjects who are scheduled for a coronary revascularization (CABG or PCI) procedure, or who have undergone a CABG procedure within three months or a PCI procedure within one month of enrollment.
12). Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated.
13). Subjects who have had a myocardial infarction within three months of enrollment.
14). Subjects who have mechanical tricuspid or aortic valves.
15). Subjects who have a prior heart transplant.
16). Subjects who have a previously implanted ICD which employs unipolar or integrated bipolar sensing
17). Subjects who are participating in another experimental protocol.
18). Subjects who are unable to provide informed consent.

研究实施时间：

Study execute time：

从 From 2010-03-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2010-03-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

One group

样本量：

 60

Group：

One group

Sample size：

干预措施：

Echocardiography assesses the Changes in Cardiac Function of heart failure by Cardiac Contractility Modulation for 4 years

干预措施代码：

Intervention：

Echocardiography assesses the Changes in Cardiac Function of heart failure by Cardiac Contractility Modulation for 4 years

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

Patient fulfilled into the study criteria will be enrolled. Baseline testing included echocardiography with RT3DE and TDI, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), 6-minute hall walk test (6MHW), maximal oxygen consumption test on treadmill test and 24-hour Holter monitor.

干预措施代码：

Intervention：

Patient fulfilled into the study criteria will be enrolled. Baseline testing included echocardiography with RT3DE and TDI, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), 6-minute hall walk test (6MHW), maximal oxygen consumption test on treadmill test and 24-hour Holter monitor.

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

Patients will be implanted with CCM. They will be followed up at pre-determined time-points where assessment will be repeated, i.e. 1week, 1 month and 3 months. After 3-month of CCM treatment, the device will be switch off. Patients will be maintained with no CCM treatment for 1 month at which time clinical and echocardiographic assessment will be repeated.

干预措施代码：

Intervention：

Patients will be implanted with CCM. They will be followed up at pre-determined time-points where assessment will be repeated, i.e. 1week, 1 month and 3 months. After 3-month of CCM treatment, the device will be switch off. Patients will be maintained with no CCM treatment for 1 month at which time clinical and echocardiographic assessment will be repeated.

Intervention code：

组别：

0

样本量：

 0

Group：

0

Sample size：

干预措施：

Afterwards, CCM will be restarted and patient will continue with long-term follow up and assessment.

干预措施代码：

Intervention：

Afterwards, CCM will be restarted and patient will continue with long-term follow up and assessment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Princess Wals Hospital of Chinese University of Hong Kong 

单位级别：

 Princess Wals Hospital of Chinese University of Hong Kong 

Institution
hospital：

Princess Wals Hospital of Chinese University of Hong Kong

Level of the institution：

Princess Wals Hospital of Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

The goal of the proposed research project is to examine the detailed mechanisms of how cardiac contractility modulation (CCM) improves cardiac function in a mechanical perspective. This can be achieved by performing serial follow up assessment based on sensitive echocardiographic tools, namely tissue Doppler imaging (TDI) and real-time 3-dimensional echocardiography (RT3DE) and 2D speckle tracking technology.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Nil

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

暂停或中断

Suspending

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 18 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

NA

Randomization Procedure (please state who generates the random number sequence and by what method)：

Nil

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

Open label

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-06-27 12:50:54