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NCT Number: NCT07033676

Serum miR-455-5p and Cardiac Structure and Function Parameters in Patients With Hypertensive Heart Disease

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Heart Disease Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

the University of Hongkong-Shenzhen Hospital

Shenzhen, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. age ≥18 years; 2. male or female; 3. systolic blood pressure ≥140mmHg or (and) diastolic blood pressure > 90mmHg; 4. history of hypertension>1year, NYHA grade I-IV

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Measurement of serum miR-455-5p level

    Time frame: 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.

  2. Measurement of LVPWd and LVPWs

    Time frame: 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.

  3. Measurement of LVIDd and LVIDs

    Time frame: 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.

  4. Measurement of IVSTd and IVSTs

    Time frame: 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.

  5. Calculation of LVMi

    Time frame: 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

  6. Measurement of LVEF

    Time frame: 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.

  7. Measurement of FS

    Time frame: 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.

  8. SBP

    Time frame: 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.

  9. DBP

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Hong Kong-Shenzhen Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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