NCT07319065

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,240

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Jan 2026

Geographic Reach
1 country

82 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 21, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

Myocardial work

Outcome Measures

Primary Outcomes (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

    At study enrollment (baseline)

Study Arms (4)

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

Patients with LBBB who have preserved LVEF

LVEF≥53%; LBBB 600 participants

Diagnostic Test: Ultrasound machine

Patients with reduced LVEF but without LBBB

LVEF ≤ 35%, non-LBBB 600 participants

Diagnostic Test: Ultrasound machine

Interventions

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.

Patients with LBBB who have preserved LVEFPatients with heart failure and left bundle branch block who are scheduled to undergo CRT treatmentPatients with reduced LVEF but without LBBB

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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
  • LVEF ≤ 35%
  • QRS ≥ 150ms; LBBB
  • At least 3 months of optimal drug therapy before implantation
  • 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;
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (82)

Anhui University of Chinese Medicine First Affiliated Hospital

Hefei, Anhui, China

Location

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wannan, Anhui, China

Location

The Provincial Hospital Affiliated to Fuzhou University

Fuzhou, Fujian, China

Location

Fujian Provincial Geriatric Hospital

Guizhou, Fujian, China

Location

Guizhou Provincial People's Hospital

Guizhou, Fujian, China

Location

Union Hospital Affiliated to Fujian Medical University

Guizhou, Fujian, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Location

Gansu Provincial People's Hospital

Lanzhou, Gansu, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Location

The First Hospital of Qinhuangdao City

Qinhuangdao, Hebei, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Longnan Hospital of Daqing Oilfield General Hospital

Daqing, Heilongjiang, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Heinan, China

Location

FuWai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

Location

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

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location

Enshi Central Hospital

Enshi, Hubei, China

Location

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

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

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

Wuhan, Hubei, China

Location

Xiangyang Hospital of Traditional Chinese Medicine, Hubei Province

Xiangyang, Hubei, China

Location

Changzhou Second People's Hospital

Changzhou, Jiangsu, China

Location

The First People's Hospital of Lianyungang City

Lianyungang, Jiangsu, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

Location

The First People's Hospital of Nantong City

Nantong, Jiangsu, China

Location

The Third People's Hospital of Nantong City

Nantong, Jiangsu, China

Location

Suqian Hospital of Jiangsu Provincial People's Hospital

Suqian, Jiangsu, China

Location

The Hospital of Traditional Chinese Medicine of Suzhou City

Suzhou, Jiangsu, China

Location

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

The Affiliated Hospital of Jiangnan University

Wuxi, Jiangsu, China

Location

The People's Hospital of Wuxi City

Wuxi, Jiangsu, China

Location

Su Bei People's Hospital

Yangzhou, Jiangsu, China

Location

The First Affiliated Hospital of Guizhou Medical University

Guizhoucun, Jiangxi, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Hospital of Jilin University

Jilin, Jilin, China

Location

The Second Hospital of Jilin University

Jilin, Jilin, China

Location

Central Hospital of Anshan City

Anshan, Liaoning, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Liaoning Golden Autumn Hospital

Shenyang, Liaoning, China

Location

Shengjing Hospital, China Medical University

Shenyang, Liaoning, China

Location

Chifeng Hospital

Chifeng, Neimenggu, China

Location

The People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China

Location

Jinan Central Hospital

Jinan, Shandong, China

Location

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

Bethea Hospital of Shanxi Province

Taiyuan, Shanxi, China

Location

Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Hospital Research Institute)

Taiyuan, Shanxi, China

Location

The Cancer Hospital of Shanxi Province

Taiyuan, Shanxi, China

Location

The People's Hospital of Shanxi Province

Taiyuan, Shanxi, China

Location

Tangdu Hospital, Air Force Medical University

Xi’an, Shanxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

The People's Hospital of Sichuan Province

Chengdu, Sichuan, China

Location

Xindu District People's Hospital of Chengdu City

Chengdu, Sichuan, China

Location

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, China

Location

The People's Hospital of Ya'an City

Ya'an, Sichuan, China

Location

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

Xinjiang, Xinjiang, China

Location

Dianxi Central Hospital of Yunnan Province

Dingxi, Yunnan, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Yan'an Hospital of Kunming City

Kunming, Yunnan, China

Location

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

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Lihuili Hospital of Ningbo Medical Center

Ningbo, Zhejiang, China

Location

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Location

The Second Hospital of Ningbo City

Ningbo, Zhejiang, China

Location

The Second Hospital of Shaoxing City

Shaoxing, Zhejiang, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

The People's Hospital of Zhuji City

Zhuji, Zhejiang, China

Location

The First Hospital of Peking University

Beijing, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Shanghai Chest Hospital

Shanghai, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chunyan Ma, MD

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunyan Ma, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cardiovascular Ultrasound

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations