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CRT Non-ResponseCARE-MWNCT07319065

Left Ventricular Myocardial Work for Predicting Response to CRT

An observational study of CRT Non-Response and LBBB, run by First Hospital of China Medical University at 82 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to establish the normal reference values for left ventricular myocardial work in healthy Chinese adults and the influencing factors. Non-invasive myocardial work serves as a new parameter for identifying CRT responders and provides a scoring system for predicting the efficacy of CRT in clinical… Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
CRT Non-Response, LBBB, HF - Heart Failure
What is being tested?
Ultrasound machine
How many people
3,240 participants
Where
82 sitesChina
Study dates
1 Jan 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: This study enrolls 4 groups (18-79 years) from clinics/community: Healthy Adults: Han Chinese with normal cardiovascular function (vitals, labs, ECG, echo; no structural heart disease/systemic diseases/poor ultrasound). Heart failure patients with LBBB who are scheduled for CRT treatment： LVEF ≤ 35%,QRS ≥ 150ms; LBBB.At least 3 months of optimal drug therapy before implantation. Patients with LBBB who have preserved LVEF :LVEF≥53%, LBBB. Patients with reduced LVEF but without LBBB :LVEF ≤ 35%,non-LBBB.

Who may be able to join

  • Participants must meet all of the following criteria to be enrolled:
  • Of Han Chinese ethnicity
  • Aged 18-79 years
  • Normal blood pressure (< 140/90 mmHg)
  • Normal fasting blood glucose
  • Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein)
Show all 17Show fewer
  • Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count)
  • Normal liver and renal function (alanine transaminase < 2× upper limit of normal; normal creatinine and blood urea nitrogen)
  • Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion)
  • No structural heart disease and normal cardiac function confirmed by echocardiography
  • LVEF ≤ 35%
  • QRS ≥ 150ms; LBBB
  • At least 3 months of optimal drug therapy before implantation
  • LVEF≥53%
  • LBBB
  • LVEF ≤ 35%
  • non-LBBB

Who cannot join

  • Participants will be excluded if they meet any of the following criteria:
  • Clinically significant cardiac valve regurgitation (≥ mild severity)
  • Respiratory diseases: acute or chronic respiratory disorders
  • Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
  • Abnormal liver function (alanine transaminase > 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein)
  • Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc.
Show all 21Show fewer
  • Pregnant or lactating women
  • Professional athletes
  • Poor-quality ultrasound images that cannot support parameter measurement and analysis
  • Heart failure patients with LBBB who are scheduled for CRT treatment Group
  • Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
  • Having a history of blood diseases and severe systemic diseases such as infections;
  • Those who cannot cooperate with the examinations.
  • Patients with LBBB who have preserved LVEF Group
  • Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
  • Having a history of blood diseases and severe systemic diseases such as infections;
  • Those who cannot cooperate with the examinations.
  • Patients with reduced LVEF but without LBBB Group
  • Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis;
  • Having a history of blood diseases and severe systemic diseases such as infections;
  • Those who cannot cooperate with the examinations.

Trial locations and contacts

82 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chunyan Ma, MD contact

+86 13998816448

mcy_echo@163.com

82 sites in 1 country

China82 sites

  • Central Hospital of Anshan City

    Anshan, Liaoning

    Yao Wang

  • The First Hospital of Peking University

    Beijing

    Ying Yang

  • Changzhou Second People's Hospital

    Changzhou, Jiangsu

    Chang Liu

  • The People's Hospital of Sichuan Province

    Chengdu, Sichuan

  • Xindu District People's Hospital of Chengdu City

    Chengdu, Sichuan

    Li Li

  • Chifeng Hospital

    Chifeng, Neimenggu

    Zhiying Cheng

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing

    Qian Dong

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

    Yang Sun

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Tao Cong

  • Longnan Hospital of Daqing Oilfield General Hospital

    Daqing, Heilongjiang

    Ling Zhang

  • Dianxi Central Hospital of Yunnan Province

    Dingxi, Yunnan

    Yong Zhou

  • Enshi Central Hospital

    Enshi, Hubei

    Kaiquan Wang

  • The Provincial Hospital Affiliated to Fuzhou University

    Fuzhou, Fujian

    Yan Zhang

  • Fujian Provincial Geriatric Hospital

    Guizhou, Fujian

    Ming Li

  • Guizhou Provincial People's Hospital

    Guizhou, Fujian

    Ying Li

  • Union Hospital Affiliated to Fujian Medical University

    Guizhou, Fujian

    Jinguo Li

  • The First Affiliated Hospital of Guizhou Medical University

    Guizhoucun, Jiangxi

    Sha Li

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

    Pei Wang

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Yan Cheng

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Wei Wu

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Ning Yang

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Xin Zhang

  • Anhui University of Chinese Medicine First Affiliated Hospital

    Hefei, Anhui

    Jie Zhang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xuegong Shi

  • Jiangmen Central Hospital

    Jiangmen, Guangdong

    Zhongzhou Su

  • The First Hospital of Jilin University

    Jilin City, Jilin

    Yong Qian

  • The Second Hospital of Jilin University

    Jilin City, Jilin

    Dongmei Lv

  • Jinan Central Hospital

    Jinan, Shandong

    Lihua Jin

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

    Haiyan Wang

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Yu Wang

  • Yan'an Hospital of Kunming City

    Kunming, Yunnan

    Zhe Meng

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu

    Yuanyuan Chu

  • The First People's Hospital of Lianyungang City

    Lianyungang, Jiangsu

    Yan Wang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xinchun Yuan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

    Yi Zhang

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

    Yonghong Yong

  • The First People's Hospital of Nantong City

    Nantong, Jiangsu

    Li Ma

  • The Third People's Hospital of Nantong City

    Nantong, Jiangsu

  • Lihuili Hospital of Ningbo Medical Center

    Ningbo, Zhejiang

  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Shengmin Zhang

  • The Second Hospital of Ningbo City

    Ningbo, Zhejiang

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yan Wen

  • The First Hospital of Qinhuangdao City

    Qinhuangdao, Hebei

  • Shanghai Chest Hospital

    Shanghai

    Fan Li

  • The Second Hospital of Shaoxing City

    Shaoxing, Zhejiang

    Kai Zheng

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Chunyan Ma, MD, +8613998816448, mcy_echo@163.com

    Chunyan Ma, MD

  • Liaoning Golden Autumn Hospital

    Shenyang, Liaoning

    Jianfeng Cao

  • Shengjing Hospital, China Medical University

    Shenyang, Liaoning

    Lin Gao

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Chong Zhao

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Chang Lv

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Ming Liu

  • Suqian Hospital of Jiangsu Provincial People's Hospital

    Suqian, Jiangsu

    Hui Liu

  • The Hospital of Traditional Chinese Medicine of Suzhou City

    Suzhou, Jiangsu

    Huijun Lai

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Changsheng Ma

  • Bethea Hospital of Shanxi Province

    Taiyuan, Shanxi

    Tianliang Li

  • Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Hospital Research Institute)

    Taiyuan, Shanxi

    Tianliang Li

  • The Cancer Hospital of Shanxi Province

    Taiyuan, Shanxi

    Runqin Miao

  • The People's Hospital of Shanxi Province

    Taiyuan, Shanxi

    Weiqin Li

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

    Gang Wang

  • The First Affiliated Hospital of Wannan Medical College

    Wannan, Anhui

    Yuanyuan Ji

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Shusheng Liao

  • Puai Hospital of Wuhan City / The Fourth Hospital of Wuhan City

    Wuhan, Hubei

    Bingyi Zhang

  • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei

    Yani Liu

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Yuman Li

  • The Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

    Qi Sun

  • The People's Hospital of Wuxi City

    Wuxi, Jiangsu

    Dajun Qian

  • Tangdu Hospital, Air Force Medical University

    Xi’an, Shanxi

    Lianbi Zhao

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Huanhuan Huo

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Yan Ge

  • Zhongshan Hospital Affiliated to Xiamen University

    Xiamen, Fujian

    Guohui Yan

  • Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province

    Xiangyang, Hubei

    Wei Shi

  • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine / The Fourth Affiliated Hospital of Xinjiang Medical University

    Xinjiang, Xinjiang

    Sha Tang

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang

    Lina Guan

  • The People's Hospital of Ya'an City

    Ya'an, Sichuan

    Jie Fang

  • Su Bei People's Hospital

    Yangzhou, Jiangsu

    Yong Chen

  • The People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Heinan

    Lin Liu

  • FuWai Central China Cardiovascular Hospital

    Zhengzhou, Henan

    Juan Cong

  • The First Affiliated Hospital of Henan Medical University (Xinxiang Medical University)

    Zhengzhou, Henan

    Ran Li

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    Zhengzhou, Henan

    Fei Wang

  • The People's Hospital of Zhuji City

    Zhuji, Zhejiang

    Yu Yang

Other trials in China

About this study

Official title: Left Ventricular Myocardial Work for Predicting Response to Cardiac Resynchronization Therapy (CRT): A Multi-Center Study

This study aims to establish the normal reference values for left ventricular myocardial work in healthy Chinese adults and the influencing factors. Non-invasive myocardial work serves as a new parameter for identifying CRT responders and provides a scoring system for predicting the efficacy of CRT in clinical practice. CRT can improve cardiac function and quality of life, and reduce mortality and hospitalization rates due to heart failure (HF). Currently, the number of CRT treatments is increasing year by year, but even when strictly following the indications, approximately 30% of patients do not respond. Therefore, precise prediction of CRT efficacy is of great clinical significance for improving prognosis. Currently, the indications for CRT mainly rely on clinical, electrocardiogram (CLBBB), and LVEF. By correcting ventricular contraction asynchrony to improve systolic function, however, CLBBB indicates electrical asynchrony, and LVEF improvement depends on mechanical synchrony. If the mechanical asynchrony of the ventricles can be evaluated directly before surgery, it will help predict the efficacy of CRT. Myocardial work is a recently developed non-invasive method that combines LV afterload with the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contraction ability of the heart, stroke work, residual myocardial contraction ability, myocardial oxygen consumption, useless work, useful work, etc., and is represented by the pressure-volume loop analysis, thus having the potential to predict the efficacy of CRT. Therefore, this study intends to adopt the left ventricular myocardial work technique, combined with the current indication criteria, to predict the long-term efficacy of patients with heart failure who are scheduled for CRT treatment, thereby increasing the response rate of CRT and improving the prognosis of patients. Currently, there are no normal reference values for left ventricular myocardial work in healthy Chinese adults. Therefore, our center has initiated this multicenter clinical research project, collaborating with multiple ultrasound centers across the country, aiming to establish the normal ultrasound values for left ventricular myocardial work in healthy Chinese adults, providing new quantitative reference basis for the diagnosis of myocardial function, assessment of the severity of myocardial lesions, and efficacy observation.

Being tested
Ultrasound machine
Keywords
Myocardial work
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound machineDiagnostic test

    Myocardial work is a recently developed non-invasive method that incorporates the LV afterload into the overall longitudinal strain (GLS) analysis of echocardiography. Myocardial work reflects the contractile ability of the heart, stroke work per beat, residual myocardial contractile ability, myocardial oxygen consumption, useless work, and useful work, which is represented by the pressure-volume loop analysis and thus has the potential to predict the efficacy of CRT.

Study groups in NCT07319065
Study groupRoleWhat they receive
Healthy Adults GroupHealthy adults aged 18 to 79 years are planned to be stratified into 6 age groups: 18-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, and ≥70 years. Each age group will include 120 participants of each sex.
Patients with heart failure and left bundle branch block who are scheduled to undergo CRT treatmentUltrasound machine LVEF ≤ 35%; QRS ≥ 150ms; LBBB; Optimal drug therapy for at least 3 months before implantation 600 participants
Receives: Diagnostic Test: Ultrasound machine
Patients with LBBB who have preserved LVEFLVEF≥53%； LBBB 600 participants
Receives: Diagnostic Test: Ultrasound machine
Patients with reduced LVEF but without LBBBLVEF ≤ 35%, non-LBBB 600 participants
Receives: Diagnostic Test: Ultrasound machine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall work index（GWI）

    The curve area representing the left ventricular PSL from the closure of the mitral valve to its opening, that is, the overall contractile work of the myocardium

    Measured: At study enrollment (baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319065
Sponsor's protocol ID
CARE-MW Study
Other IDs
General Electric Healthcare
Acronym
CARE-MW
Status last verified
Dec 2025
First submitted
21 Dec 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of CRT Non-Response and LBBB, run by First Hospital of China Medical University at 82 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chunyan Ma, MD (+86 13998816448, mcy_echo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall work index（GWI） (time frame: At study enrollment (baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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