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临床试验/NCT07033676
NCT07033676Enrolling By Invitation不适用

Study on the Correlation Between Serum miR-455-5p Level and Cardiac Structure and Function Parameters in Patients With Hypertensive Heart Disease

The University of Hong Kong-Shenzhen Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
46
试验地点
1
主要终点
Measurement of serum miR-455-5p level

研究概览

简要总结

Hypertensive heart disease (HHD) is the leading cause of mortality and morbidity worldwide. In 2017, the prevalence of HHD worldwide was 217.9 per 100,000 people, an increase of 7.4% over 1990, which has brought huge financial burden and social and economic losses to the world. Therefore, HHD is a major public health challenge worldwide. In our previous studies, we found that miR-455-5p, a microRNA, could functioned as an inducer to promote cardiac hypertrophy. Because cardiac hypertrophy was a common phenomenon in patients with HHD, so it is interesting to clarify whether miR-455-5p could be employed as a marker to indicate the function and/or structure of heart in the development of HHD. Thus, the purpose of this study was to collect blood samples of hypertensive patients, as well as analysis the correlation between serum miR-455-5p level and cardiac function. The research could help doctors better predict the course of hypertensive heart disease and provide more effective treatments for different patients.

详细描述

The purpose of this study was to collect blood samples of hypertensive patients, in order to clarify the correlation between serum miR-455-5p level and cardiac function. Generally, by using q-PCR assay, miR-455-5p level of each participants will be collected. Besides, SBP, DBP, LVPWd, LVIDd, IVSTd was detected by echocardiography and EF, FS, LVMi, RWT level was further calculated by LVIDd, LVPWd and IVSTd. Finally, the correlation of miR-455-5p level of HHD patients and LVPWd, LVIDd, IVSTd, EF, FS, LVMi, RWT, SBP, DBP was analysed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • •age ≥18 years;
  • •male or female;
  • •systolic blood pressure ≥140mmHg or (and) diastolic blood pressure > 90mmHg;
  • •history of hypertension>1year, NYHA grade I-IV

排除标准

  • •hypertensive heart diseases patients with other metabolic diseases or congenital diseases were excluded from the study

结局指标

主要结局

Measurement of serum miR-455-5p level

时间窗: the miR-455-5p level is collected at week 0, 6, 12 and 24.

concentration of microRNA-455-5p in 100ml serum was determined by Elisa assay.

Measurement of LVPWd and LVPWs

时间窗: the LVPWd and LVPWs are collected at week 0, 6, 12 and 24.

left ventricular posterior wall thickness in diastole state and systole state are measured and recorded by echocardiography and its affiliated software.

Measurement of LVIDd and LVIDs

时间窗: the LVIDd and LVIDs are collected at week 0, 6, 12 and 24.

left ventricular internal diameter in diastole state and systole state are measured and recorded by echocardiography and its affiliated software.

Measurement of IVSTd and IVSTs

时间窗: the IVSTd and IVSTs are collected at week 0, 6, 12 and 24.

interventricular septum in diastole state and systole state are measured and recorded by echocardiography and its affiliated software.

Calculation of LVMi

时间窗: the LVMi is calculated at week 0, 6, 12 and 24.

left ventricular mass index was calculated based on the formula: LVMi=LVM/BSA; For LVM, LVM(g)=0.8\*1.04\*\[(IVSTd+LVPWd+LVIDd)\^3-LVIDd\^3\]+0.6; For BSA, BSA=\[Body height (cm)\*Body weight (kg)/3600\]\^0.5; Diagnosis of LVH: LVMi(Male)\>115g/m2;LVMi(Female)\>95g/m2

Measurement of LVEF

时间窗: the EF is calculated at week 0, 6, 12 and 24.

left ventricular ejection fraction are measured and recorded by echocardiography and its affiliated software. Generally, LVEF is range from 50% to 70% is regarded as normal. If LVEF less than 50%, the patient is suspected to suffered cardiac systolic dysfunction.

Measurement of FS

时间窗: the FS is calculated at week 0, 6, 12 and 24.

Fractional shortening are measured and recorded by echocardiography and its affiliated software. Generally, FS is range from 25% to 45% is regarded as normal. If FS less than 25%, the patient is suspected to suffered cardiac systolic dysfunction.

SBP

时间窗: the SBP is collected at week 0, 6, 12 and 24.

systolic blood pressure was measured by sphygmomanometer. For patients whose SBP is higher than 140mmHg, the patients is regarded as hypertension.

DBP

时间窗: the DBP is collected at week 0, 6, 12 and 24.

diastolic blood pressure was measured by sphygmomanometer. For patients whose DBP is higher than 90mmHg, the patients is regarded as hypertension.

次要结局

未报告次要终点

研究者

发起方
The University of Hong Kong-Shenzhen Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cai Sidong

Assistant research fellow

The University of Hong Kong-Shenzhen Hospital

研究点 (1)

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