HypertensionNCT07033676
Serum miR-455-5p and Cardiac Structure and Function Parameters in Patients With Hypertensive Heart Disease
An observational study of Hypertension and Heart Disease, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Heart Disease
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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].
Who may be able to join
- 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
Who cannot join
- hypertensive heart diseases patients with other metabolic diseases or congenital diseases were excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Correlation Between Serum miR-455-5p Level 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.
Read the detailed description
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.
- Conditions
- Hypertension, Heart Disease
- Keywords
- miR-455-5p, hypertensive heart disease
- Medical subject headings
- Hypertension, Heart Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of serum miR-455-5p level
concentration of microRNA-455-5p in 100ml serum was determined by Elisa assay.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: the DBP is collected at week 0, 6, 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Sidong, The University of Hong Kong-Shenzhen Hospital
- Investigators
- Assistant research fellow, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033676
- Sponsor's protocol ID
- caisd@hku-szh.org
- Other IDs
- 82300446, 2022A1515111093, RCBS20231211090745071
- Status last verified
- Jun 2025
- First submitted
- 8 Dec 2023
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between Serum miR-455-5p Level and Cardiac Structure and Function Parameters in Patients With Hypertensive Heart Disease
- ClinicalTrials.gov ID
- NCT07033676
- Acronym / sponsor ID
- caisd@hku-szh.org
- Conditions
- Hypertension, Heart Disease
- Keywords
- miR-455-5p, hypertensive heart disease
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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].
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- hypertensive heart diseases patients with other metabolic diseases or congenital diseases were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Assistant research fellow principal investigator
The University of Hong Kong-Shenzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Heart Disease, run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of serum miR-455-5p level (time frame: the miR-455-5p level is collected at week 0, 6, 12 and 24.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.