Left Ventricular Myocardial Work for Predicting Response to CRT

Официальное название

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

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• Overall work index（GWI） [Срок оценки: At study enrollment (baseline)]

Критерии участия

Healthy Adults Group

Критерии включения

• 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

Критерии исключения

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

Критерии включения

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

Критерии исключения

• 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

Критерии включения

• LVEF≥53%
• LBBB

Критерии исключения

• 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

Критерии включения

• LVEF ≤ 35%
• non-LBBB

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 82 центра

• Anhui University of Chinese Medicine First Affiliated Hospital — Хэфэй
• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• The First Affiliated Hospital of Wannan Medical College — Wannan
• The Provincial Hospital Affiliated to Fuzhou University — Фучжоу
• Fujian Provincial Geriatric Hospital — Guizhou
• Guizhou Provincial People's Hospital — Guizhou
• Union Hospital Affiliated to Fujian Medical University — Guizhou
• The First Affiliated Hospital of Xiamen University — Xiamen
• … и ещё 74 центра

Идентификаторы

NCT: NCT07319065 · CARE-MW Study · General Electric Healthcare

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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