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NCT07319065Not yet recruiting

Left Ventricular Myocardial Work for Predicting Response to CRT

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

Source: ClinicalTrials.gov · Last updated 6 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
3240 (estimated)
First submitted
21 Dec 2025
Start date
Jan 2026
Primary completion date
Dec 2026
Lead sponsor
First Hospital of China Medical University
NCT number
NCT07319065

What you commit to

  • Study type: Observational
  • Planned participants: 3240
  • From Jan 2026 to the primary completion date, Dec 2026
  • 82 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Clinically significant cardiac valve regurgitation (≥ mild severity)
  • Respiratory diseases: acute or chronic respiratory disorders
  • Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc.
  • 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.
  • 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;
  • 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;
  • 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;

Lab values

  • 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)
  • Those who cannot cooperate with the examinations.
    • Patients with LBBB who have preserved LVEF Group
  • Those who cannot cooperate with the examinations.
    • Patients with reduced LVEF but without LBBB Group

Other

  • Participants will be excluded if they meet any of the following criteria:
  • Pregnant or lactating women
  • Professional athletes
  • Those who cannot cooperate with the examinations.

Who the study is looking for

  • 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)
    • 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

Criteria the registry did not label

  • Healthy Adults Group

Age in the registry: 18 years to 79 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (82)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Central Hospital of Anshan City
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AnshanChinaUnknown status
The first hospital of Peking University
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BeijingChinaUnknown status
Changzhou Second People's Hospital
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ChangzhouChinaUnknown status
The People's Hospital of Sichuan Province
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ChengduChinaUnknown status
Xindu District People's Hospital of Chengdu City
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ChengduChinaUnknown status
Chifeng Hospital
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ChifengChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
The Second Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
The First Affiliated Hospital of Dalian Medical University
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DalianChinaUnknown status
Longnan Hospital of Daqing Oilfield General Hospital
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DaqingChinaUnknown status
Dianxi Central Hospital of Yunnan Province
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DingxiChinaUnknown status
Enshi Central Hospital
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EnshiChinaUnknown status
The Provincial Hospital Affiliated to Fuzhou University
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FuzhouChinaUnknown status
Guizhou Provincial People's Hospital
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GuizhouChinaUnknown status
Fujian Provincial Geriatric Hospital
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GuizhouChinaUnknown status
Union Hospital Affiliated to Fujian Medical University
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GuizhouChinaUnknown status
The First Affiliated Hospital of Guizhou Medical University
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GuizhoucunChinaUnknown status
The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
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HangzhouChinaUnknown status
The First Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
The Fourth Affiliated Hospital of Harbin Medical University
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HarbinChinaUnknown status
Anhui University of Chinese Medicine First Affiliated Hospital
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HefeiChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Jiangmen Central Hospital
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JiangmenChinaUnknown status
The First Hospital of Jilin University
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Jilin CityChinaUnknown status
The Second Hospital of Jilin University
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Jilin CityChinaUnknown status
Jinan Central Hospital
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JinanChinaUnknown status
The First Affiliated Hospital of Shandong First Medical University
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JinanChinaUnknown status
Yan'an Hospital of Kunming City
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KunmingChinaUnknown status
The First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Gansu Provincial People's Hospital
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LanzhouChinaUnknown status
The First People's Hospital of Lianyungang City
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LianyungangChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
Affiliated Hospital of North Sichuan Medical College
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NanchongChinaUnknown status
Jiangsu Provincial People's Hospital
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NanjingChinaUnknown status
The Third People's Hospital of Nantong City
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NantongChinaUnknown status
The First People's Hospital of Nantong City
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NantongChinaUnknown status
The second hospital of Ningbo City
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NingboChinaUnknown status
Lihuili Hospital of Ningbo Medical Center
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NingboChinaUnknown status
The First Affiliated Hospital of Ningbo University
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NingboChinaUnknown status
The Affiliated Hospital of Qingdao University
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QingdaoChinaUnknown status
The First Hospital of Qinhuangdao City
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QinhuangdaoChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
The Second Hospital of Shaoxing City
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ShaoxingChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
Liaoning Golden Autumn Hospital
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ShenyangChinaUnknown status
Shengjing Hospital, China Medical University
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ShenyangChinaUnknown status
The Third Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The First Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Suqian Hospital of Jiangsu Provincial People's Hospital
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SuqianChinaUnknown status
The Second Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
The Hospital of Traditional Chinese Medicine of Suzhou City
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SuzhouChinaUnknown status
The Cancer Hospital of Shanxi Province
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TaiyuanChinaUnknown status
Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Hospital Research Institute)
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TaiyuanChinaUnknown status
Bethea Hospital of Shanxi Province
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TaiyuanChinaUnknown status
The People's Hospital of Shanxi Province
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TaiyuanChinaUnknown status
Taizhou Hospital of Zhejiang Province
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TaizhouChinaUnknown status
The First Affiliated Hospital of Wannan Medical College
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WannanChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Puai Hospital of Wuhan City / The Fourth Hospital of Wuhan City
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WuhanChinaUnknown status
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
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WuhanChinaUnknown status
The Affiliated Hospital of Jiangnan University
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WuxiChinaUnknown status
The People's Hospital of Wuxi City
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WuxiChinaUnknown status
Zhongshan Hospital Affiliated to Xiamen University
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XiamenChinaUnknown status
The First Affiliated hospital of Xiamen University
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XiamenChinaUnknown status
The Second Affiliated Hospital of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Tangdu Hospital, Air Force Medical University
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Xi'anChinaUnknown status
Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province
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XiangyangChinaUnknown status
The First Affiliated Hospital of Xinjiang Medical University
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XinjiangChinaUnknown status
Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine / The Fourth Affiliated Hospital of Xinjiang Medical University
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XinjiangChinaUnknown status
The People's Hospital of Ya'an City
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Ya'anChinaUnknown status
Su Bei People's Hospital
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YangzhouChinaUnknown status
The People's Hospital of Ningxia Hui Autonomous Region
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YinchuanChinaUnknown status
The First Affiliated Hospital of Henan University of Chinese Medicine
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Fuwai Central China Cardiovascular Hospital
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ZhengzhouChinaUnknown status
The First Affiliated Hospital of Henan Medical University (Xinxiang Medical University)
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ZhengzhouChinaUnknown status
The People's Hospital of Zhuji City
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ZhujiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.