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临床试验/NCT06683872
NCT06683872Enrolling By Invitation不适用

Evaluation of Clinical Efficacy and Prognosis in Patients with Hypertrophic Obstructive Cardiomyopathy Through Hemodynamic Modeling Reconstructed by CT

Zhejiang Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
200
试验地点
1
主要终点
Changes in left ventricular outflow tract pressure immediately after surgery and at 1 year postoperatively

研究概览

简要总结

Hypertrophic cardiomyopathy (HCM) is a common autosomal dominant inherited heart disease, with previous data suggesting a prevalence of approximately 1 in 500 in the population. However, with the widespread use of genetic testing and high-sensitivity cardiac imaging in recent years, the estimated prevalence of HCM may be as high as 1 in 200. Approximately 75% of HCM patients will develop left ventricular outflow tract obstruction (LVOTO), leading to decreased exercise capacity, dyspnea, syncope, heart failure, and even sudden death, significantly impacting the patients' quality of life and survival.

The optimal treatment for hypertrophic obstructive cardiomyopathy (HOCM) is still a matter of controversy, despite surgical myectomy being considered the "gold standard" for HOCM treatment. Treatment options such as chemical (radiofrequency) ablation and medications (Mavacamten) are also challenging the status, and there is even debate over the surgical approach for myectomy. Currently, there is no consensus in the medical community about the pathophysiological mechanisms of LVOTO, and the exact mechanisms of its occurrence are not fully understood, which is also a major reason for the treatment controversy in HOCM patients.

The focus of clinical decision-making is on the treatment based on the LVOTO pressure gradient, and it is generally recommended internationally to consider invasive treatment when the LVOTO pressure gradient is ≥50mmHg. However, there are still a small number of patients who do not have symptoms with a pressure gradient greater than 50mmHg or have significant symptoms with a pressure gradient less than 50mmHg, indicating that relying solely on the pressure gradient to assess the severity of HOCM and its prognosis may not be comprehensive enough.

In recent years, with the development of medical engineering integration, the use of computational fluid dynamics (CFD) in the medical field, particularly in the field of cardiovascular diseases, has become increasingly widespread. CFD can construct cardiovascular geometric models based on specific clinical images of a patient and simulate ventricular wall motion and blood flow within the heart through computer calculations to obtain the required hemodynamic parameters. This enables the visualization and quantification of intraventricular blood flow. Compared to direct measurement techniques based on imaging, CFD has advantages such as non-invasiveness, comprehensiveness, and accuracy, leading to its increasing application in cardiovascular function research. In particular, in the field of cardiomyopathy, CFD can help deepen the understanding of the pathophysiological mechanisms of hypertrophic obstructive cardiomyopathy by reconstructing the anatomical configuration of the left ventricle and analyzing intraventricular blood flow and related hemodynamic parameters, which in turn can aid in clinical decision-making and the assessment of clinical prognosis. Therefore, we propose using three-dimensional (3D) computed tomography (CT) simulation technology to assess the hemodynamics of patients with hypertrophic obstructive cardiomyopathy, in order to guide clinical decision-making.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-70 years old
  • Maximum interventricular septum thickness ≥15mm
  • Dynamic left ventricular outflow tract gradient at rest or with provocation (Valsalva maneuver or exercise) ≥50mmHg
  • New York Heart Association (NYHA) functional classification ≥II
  • Presence of severe symptoms despite maximal medical therapy (maximal medical therapy for HCM may include combination of disopyramide and/or β-blockers and calcium channel blockers)

排除标准

  • Combined with other heart diseases that require surgical treatment, such as heart valve disease or coronary artery atherosclerotic heart disease.
  • Left ventricular ejection fraction <40%.
  • Presence of the following arrhythmias: atrial fibrillation, QT interval > 500ms, occurrence of sustained ventricular tachycardia in the past 6 months before screening.
  • Allergy to iodine contrast agents.

结局指标

主要结局

Changes in left ventricular outflow tract pressure immediately after surgery and at 1 year postoperatively

时间窗: From operation to one year postoperatively

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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