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Clinical Trials in China / NCT07319065
Starting soon Observational

Left Ventricular Myocardial Work for Predicting Response to CRT

NCT07319065 · tracked via the Priya Life Science China tracker
Sponsor
First Hospital of China Medical University
Phase
Observational
Started
2026-01-01
Last updated
2026-01-06

Condition(s) studied

CRT Non-ResponseLBBBHF - Heart FailureHealthy Adult

Investigational drug(s) / intervention(s)

Ultrasound machine

Ultrasound machine: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
79 Years
Healthy volunteers
Accepted
Healthy Adults Group Inclusion Criteria: * Participants must meet all of the following criteria to be enrolled: 1. Of Han Chinese ethnicity 2. Aged 18-79 years 3. Normal blood pressure (\< 140/90 mmHg) 4. Normal fasting blood glucose 5. Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein) 6. Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count) 7. Normal liver and renal function (alanine transaminase \< 2× upper limit of normal; normal creatinine and blood urea nitrogen) 8. Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion) 9. No structural heart disease and normal cardiac function confirmed by echocardiography Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: 1. Clinically significant cardiac valve regurgitation (≥ mild severity) 2. Respiratory diseases: acute or chronic respiratory disorders 3. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc. 4. 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) 5. 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. 6. Pregnant or lactating women 7. Professional athletes 8. Poor-quality ultrasound images that cannot support parameter measurement and analysis Heart failure patients with LBBB who are scheduled for CRT treatment Group Inclusion criteria: 1. LVEF ≤ 35% 2. QRS ≥ 150ms; LBBB 3. At least 3 months of optimal drug therapy before implantation Exclusion Criteria: 1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis; 2. Having a history of blood diseases and severe systemic diseases such as infections; 3. Those who cannot cooperate with the examinations. Patients with LBBB who have preserved LVEF Group Inclusion criteria: 1. LVEF≥53% 2. LBBB Exclusion Criteria: 1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis; 2. Having a history of blood diseases and severe systemic diseases such as infections; 3. Those who cannot cooperate with the examinations. Patients with reduced LVEF but without LBBB Group Inclusion criteria: 1. LVEF ≤ 35% 2. non-LBBB Exclusion Criteria: 1. Suffering from connective tissue diseases such as systemic lupus erythematosus, polymyositis, and rheumatoid arthritis; 2. Having a history of blood diseases and severe systemic diseases such as infections; 3. Those who cannot cooperate with the examinations.

Primary outcome measure(s)

Trial sites (82)

FacilityCityRegionStatus
Anhui University of Chinese Medicine First Affiliated Hospital Hefei Anhui
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
The First Affiliated Hospital of Wannan Medical College Wannan Anhui
The Provincial Hospital Affiliated to Fuzhou University Fuzhou Fujian
Fujian Provincial Geriatric Hospital Guizhou Fujian
Guizhou Provincial People's Hospital Guizhou Fujian
Union Hospital Affiliated to Fujian Medical University Guizhou Fujian
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Zhongshan Hospital Affiliated to Xiamen University Xiamen Fujian
Gansu Provincial People's Hospital Lanzhou Gansu
Jiangmen Central Hospital Jiangmen Guangdong
The First Hospital of Qinhuangdao City Qinhuangdao Hebei
The First Hospital of Hebei Medical University Shijiazhuang Hebei
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
The Third Hospital of Hebei Medical University Shijiazhuang Hebei
Longnan Hospital of Daqing Oilfield General Hospital Daqing Heilongjiang
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
The First Affiliated Hospital of Zhengzhou University Zhengzhou Heinan
FuWai Central China Cardiovascular Hospital Zhengzhou Henan
The First Affiliated Hospital of Henan Medical University (Xinxiang Medical University) Zhengzhou Henan
The First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou Henan
Enshi Central Hospital Enshi Hubei
Puai Hospital of Wuhan City / The Fourth Hospital of Wuhan City Wuhan Hubei
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province Xiangyang Hubei
Changzhou Second People's Hospital Changzhou Jiangsu
The First People's Hospital of Lianyungang City Lianyungang Jiangsu
Jiangsu Provincial People's Hospital Nanjing Jiangsu
The First People's Hospital of Nantong City Nantong Jiangsu
The Third People's Hospital of Nantong City Nantong Jiangsu
Suqian Hospital of Jiangsu Provincial People's Hospital Suqian Jiangsu
The Hospital of Traditional Chinese Medicine of Suzhou City Suzhou Jiangsu
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
The Affiliated Hospital of Jiangnan University Wuxi Jiangsu
The People's Hospital of Wuxi City Wuxi Jiangsu
Su Bei People's Hospital Yangzhou Jiangsu
The First Affiliated Hospital of Guizhou Medical University Guizhoucun Jiangxi
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi

+ 42 more sites — see the full list on the official registry below.

More First Hospital of China Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07319065 on ClinicalTrials.gov ↗ ← All trials in China