Left Ventricular Myocardial Work for Predicting Response to CRT (CARE-MW)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult; LBBB; HF - Heart Failure; CRT Non-Response
• Intervention / Treatment: Diagnostic test: Ultrasound machine

• Study Type: Observational
• Enrollment (Estimated): 3240

Contacts and Locations

• Study Contact: Name: Chunyan Ma, MD; Phone Number: +86 13998816448; Email: mcy_echo@163.com

Study Locations

• China
  • Beijing, China
    • The First Hospital of Peking University
    • Contact: Ying Yang
  • Chongqing, China
    • The First Affiliated Hospital of Chongqing Medical University
    • Contact: Qian Dong
  • Chongqing, China
    • The Second Affiliated Hospital of Chongqing Medical University
    • Contact: Yang Sun
  • Shanghai, China
    • Shanghai Chest Hospital
    • Contact: Fan Li
  • Xinjiang, China
    • The First Affiliated Hospital of Xinjiang Medical University
    • Contact: Lina Guan
  • Anhui
    • Hefei, Anhui, China
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Xuegong Shi
    • Hefei, Anhui, China
      • Anhui University of Chinese Medicine First Affiliated Hospital
      • Contact: Jie Zhang
    • Wannan, Anhui, China
      • The First Affiliated Hospital of Wannan Medical College
      • Contact: Yuanyuan Ji
  • Fujian
    • Fuzhou, Fujian, China
      • The Provincial Hospital Affiliated to Fuzhou University
      • Contact: Yan Zhang
    • Guizhou, Fujian, China
      • Fujian Provincial Geriatric Hospital
      • Contact: Ming Li
    • Guizhou, Fujian, China
      • Guizhou Provincial People's Hospital
      • Contact: Ying Li
    • Guizhou, Fujian, China
      • Union Hospital Affiliated to Fujian Medical University
      • Contact: Jinguo Li
    • Xiamen, Fujian, China
      • The First Affiliated Hospital of Xiamen University
      • Contact: Yan Ge
    • Xiamen, Fujian, China
      • Zhongshan Hospital Affiliated to Xiamen University
      • Contact: Guohui Yan
  • Gansu
    • Lanzhou, Gansu, China
      • Gansu Provincial People's Hospital
      • Contact: Yuanyuan Chu
  • Guangdong
    • Jiangmen, Guangdong, China
      • Jiangmen Central Hospital
      • Contact: Zhongzhou Su
  • Hebei
    • Qinhuangdao, Hebei, China
      • The First Hospital of Qinhuangdao City
    • Shijiazhuang, Hebei, China
      • The Third Hospital of Hebei Medical University
      • Contact: Ming Liu
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
      • Contact: Chong Zhao
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
      • Contact: Chang Lv
  • Heilongjiang
    • Daqing, Heilongjiang, China
      • Longnan Hospital of Daqing Oilfield General Hospital
      • Contact: Ling Zhang
    • Harbin, Heilongjiang, China
      • The Fourth Affiliated Hospital of Harbin Medical University
      • Contact: Xin Zhang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Ning Yang
  • Heinan
    • Zhengzhou, Heinan, China
      • the First Affiliated Hospital of Zhengzhou University
      • Contact: Lin Liu
  • Henan
    • Zhengzhou, Henan, China
      • Fuwai Central China Cardiovascular Hospital
      • Contact: Juan Cong
    • Zhengzhou, Henan, China
      • the First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Fei Wang
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Henan Medical University (Xinxiang Medical University)
      • Contact: Ran Li
  • Hubei
    • Enshi, Hubei, China
      • Enshi Central Hospital
      • Contact: Kaiquan Wang
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Yuman Li
    • Wuhan, Hubei, China
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Yani Liu
    • Wuhan, Hubei, China
      • Puai Hospital of Wuhan City / The Fourth Hospital of Wuhan City
      • Contact: Bingyi Zhang
    • Xiangyang, Hubei, China
      • Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province
      • Contact: Wei Shi
  • Jiangsu
    • Changzhou, Jiangsu, China
      • Changzhou Second People's Hospital
      • Contact: Chang Liu
    • Lianyungang, Jiangsu, China
      • The First People's Hospital of Lianyungang City
      • Contact: Yan Wang
    • Nanjing, Jiangsu, China
      • Jiangsu Provincial People's Hospital
      • Contact: Yonghong Yong
    • Nantong, Jiangsu, China
      • The First People's Hospital of Nantong City
      • Contact: Li Ma
    • Nantong, Jiangsu, China
      • The Third People's Hospital of Nantong City
    • Suqian, Jiangsu, China
      • Suqian Hospital of Jiangsu Provincial People's Hospital
      • Contact: Hui Liu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University
      • Contact: Changsheng Ma
    • Suzhou, Jiangsu, China
      • The Hospital of Traditional Chinese Medicine of Suzhou City
      • Contact: Huijun Lai
    • Wuxi, Jiangsu, China
      • The Affiliated Hospital of Jiangnan University
      • Contact: Qi Sun
    • Wuxi, Jiangsu, China
      • The People's Hospital of Wuxi City
      • Contact: Dajun Qian
    • Yangzhou, Jiangsu, China
      • Su Bei People's Hospital
      • Contact: Yong Chen
  • Jiangxi
    • Guizhoucun, Jiangxi, China
      • The First Affiliated Hospital of Guizhou Medical University
      • Contact: Sha Li
    • Nanchang, Jiangxi, China
      • The Second Affiliated Hospital of Nanchang University
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
      • Contact: Xinchun Yuan
  • Jilin
    • Jilin, Jilin, China
      • The First Hospital of Jilin University
      • Contact: Yong Qian
    • Jilin, Jilin, China
      • The Second Hospital of Jilin University
      • Contact: Dongmei Lv
  • Liaoning
    • Anshan, Liaoning, China
      • Central Hospital of Anshan City
      • Contact: Yao Wang
    • Dalian, Liaoning, China
      • The First Affiliated Hospital of Dalian Medical University
      • Contact: Tao Cong
    • Shenyang, Liaoning, China, 110000
      • The First Hospital of China Medical University
      • Contact: Chunyan Ma, MD; Phone Number: +8613998816448; Email: mcy_echo@163.com
      • Contact: Chunyan Ma, MD
    • Shenyang, Liaoning, China
      • Liaoning Golden Autumn Hospital
      • Contact: Jianfeng Cao
    • Shenyang, Liaoning, China
      • Shengjing Hospital, China Medical University
      • Contact: Lin Gao
  • Neimenggu
    • Chifeng, Neimenggu, China
      • Chifeng Hospital
      • Contact: Zhiying Cheng
  • Ningxia
    • Yinchuan, Ningxia, China
      • The People's Hospital of Ningxia Hui Autonomous Region
  • Shandong
    • Jinan, Shandong, China
      • Jinan Central Hospital
      • Contact: Lihua Jin
    • Jinan, Shandong, China
      • The First Affiliated Hospital of Shandong First Medical University
      • Contact: Haiyan Wang
    • Qingdao, Shandong, China
      • The affiliated hospital of Qingdao university
      • Contact: Yan Wen
  • Shanxi
    • Taiyuan, Shanxi, China
      • Bethea Hospital of Shanxi Province
      • Contact: Tianliang Li
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Hospital Research Institute)
      • Contact: Tianliang Li
    • Taiyuan, Shanxi, China
      • The Cancer Hospital of Shanxi Province
      • Contact: Runqin Miao
    • Taiyuan, Shanxi, China
      • The People's Hospital of Shanxi Province
      • Contact: Weiqin Li
    • Xi’an, Shanxi, China
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Huanhuan Huo
    • Xi’an, Shanxi, China
      • Tangdu Hospital, Air Force Medical University
      • Contact: Lianbi Zhao
  • Sichuan
    • Chengdu, Sichuan, China
      • The People's Hospital of Sichuan Province
    • Chengdu, Sichuan, China
      • Xindu District People's Hospital of Chengdu City
      • Contact: Li Li
    • Nanchong, Sichuan, China
      • Affiliated Hospital of North Sichuan Medical College
      • Contact: Yi Zhang
    • Ya'an, Sichuan, China
      • The People's Hospital of Ya'an City
      • Contact: Jie Fang
  • Xinjiang
    • Xinjiang, Xinjiang, China
      • Xinjiang Uygur Autonomous Region Hospital of Traditional Chinese Medicine / The Fourth Affiliated Hospital of Xinjiang Medical University
      • Contact: Sha Tang
  • Yunnan
    • Dingxi, Yunnan, China
      • Dianxi Central Hospital of Yunnan Province
      • Contact: Yong Zhou
    • Kunming, Yunnan, China
      • Yan'an Hospital of Kunming City
      • Contact: Zhe Meng
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University
      • Contact: Yu Wang
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Yan Cheng
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: Wei Wu
    • Hangzhou, Zhejiang, China
      • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
      • Contact: Pei Wang
    • Ningbo, Zhejiang, China
      • The First Affiliated Hospital of Ningbo University
      • Contact: Shengmin Zhang
    • Ningbo, Zhejiang, China
      • Lihuili Hospital of Ningbo Medical Center
    • Ningbo, Zhejiang, China
      • The Second Hospital of Ningbo City
    • Shaoxing, Zhejiang, China
      • The Second Hospital of Shaoxing City
      • Contact: Kai Zheng
    • Taizhou, Zhejiang, China
      • Taizhou Hospital of Zhejiang Province
      • Contact: Gang Wang
    • Wenzhou, Zhejiang, China
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Shusheng Liao
    • Zhuji, Zhejiang, China
      • The People's Hospital of Zhuji City
      • Contact: Yu Yang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Adults Group; Healthy 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 treatment; Ultrasound machine LVEF ≤ 35%; QRS ≥ 150ms; LBBB; Optimal drug therapy for at least 3 months before implantation 600 participants	Diagnostic test: 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.
Patients with LBBB who have preserved LVEF; LVEF≥53%； LBBB 600 participants	Diagnostic test: 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.
Patients with reduced LVEF but without LBBB; LVEF ≤ 35%, non-LBBB 600 participants	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At study enrollment (baseline)

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University
• Investigators: Principal Investigator: Chunyan Ma, MD, First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 21, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial work
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CARE-MW Study; General Electric Healthcare (Other Grant/Funding Number: General Electric Healthcare Systems Trade Development (Shanghai) Co., Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No