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

NCT07033676 | Enrolling By Invitation

• 4 other identifiers: caisd@hku-szh.org823004462022A1515111093RCBS20231211090745071
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Heart Disease

Keywords

miR-455-5p; hypertensive heart disease

Outcome Measures

Primary Outcomes (9)

• Measurement of serum miR-455-5p level

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

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

• Measurement of LVPWd and LVPWs

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

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

• Measurement of LVIDd and LVIDs

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

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

• Measurement of IVSTd and IVSTs

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

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

• Calculation of LVMi

  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

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

• Measurement of LVEF

  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.

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

• Measurement of FS

  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.

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

• SBP

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

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

• DBP

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

45 patients with hypertensive heart disease admitted to Hong-Kong University, Shenzhen Hospital from January 1 to March 10 in 2021 were included in our study. Hypertensive heart disease was defined using the International Classification of Diseases, Ninth and Tenth Revision (ICD-10) codes. Diseases coded as I11.0 and I11.9 in ICD-10 were identified as hypertensive heart disease\[1-2\].

You may qualify if:

• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead

Study Sites (1)

the University of Hongkong-Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hypertension; Heart Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Assistant research fellow

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant research fellow

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: June 24, 2025
• Study Start: January 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (1)