HypertensionNCT05638503
Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
An observational study of Hypertension, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Left ventricular hypertrophy and Left ventricular non-hypertrophy
- How many people
- 2,200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2027
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg
Who may be able to join
- Age 30-75 years old;
- No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg;
- Left ventricular ejection fraction was normal (LVEF ≥ 0.5).
- All patients agreed to participate in the experiment and signed the informed consent form.
Who cannot join
- Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;
- Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;
- Abnormal liver function; abnormal renal function and diabetes;
- Pregnant or breastfeeding women;
- Expected survival time due to non-cardiovascular disease<4 years;
- Patients with poor echocardiographic image quality.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Lijuan Bu, PhD, +86-18560088816, qlyykyc@163.ocm
About this study
The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Then the investigators want to enroll twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up. Echocardiographic measurement parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
Read the detailed description
Different configurations of hypertension are important risk factor for the morbidity and mortality of cardiovascular and cerebrovascular diseases in China. Studies have shown that left ventricular hypertrophy (LVH) and left atrial enlargement caused by hypertension are independent risk factors for cardiovascular events. The LVM and LAV derived from the normal value data of Chinese healthy adults have been reported to be different from the recommended reference values in guidelines, and the distribution characteristics of hypertension remodeling are also different. However, the characteristics and outcomes of cardiac remodeling in Chinese hypertensive population and whether this difference in configuration has an impact on the treatment, prognosis and cardiovascular events of hypertensive population are still needed to be explored.
This study was to observe the relationship between blood pressure and cardiovascular remodeling evaluated by different standards in hypertensive population, and compare the relationship between different cardiac configurations and cardiovascular events in Chinese hypertensive population.
Twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up.
Echocardiographic measurement parameters including M-mode and two-dimensional ultrasonic parameters; doppler ultrasound parameters; relevant parameters of two-dimensional speckle tracking, myocardial work parameters; the left ventricular remodeling parameters (LVM and RWT); cardiac morphological changes; three-dimensional ultrasound parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
- Conditions
- Hypertension
- Being tested
- Left ventricular hypertrophy, Left ventricular non-hypertrophy
- Keywords
- Hypertension, Echocardiography, Cardiovascular remodeling
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left ventricular hypertrophyOther
Hypertension with normal left ventricular geometry and left ventricular concentric remodeling
Left ventricular non-hypertrophyOther
Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy
| Study group | Role | What they receive |
|---|---|---|
| Hypertension with left ventricular hypertrophy group | 2015 ASE/EACVI guideline standard: Eccentric hypertrophy, EH: LVMI>115g/ m2（male）or LVMI>95g/ m2（female）and RWT≤0.42 Concentric hypertrophy, CH: LVMI>115g/ m2（male）or LVMI>95g/ m2（female）and RWT>0.42
Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:
Eccentric hypertrophy, EH: LVMI>108g/ m2（male）and RWT≤0.51or LVMI>99g/ m2（female）and RWT≤0.49 Concentric hypertrophy, CH: LVMI>108g/ m2（male）and RWT>0.51 or LVMI>99g/ m2（female）and RWT>0.49 Receives: Other: Left ventricular hypertrophy | |
| Hypertension with left ventricular non-hypertrophy group | 2015 ASE/EACVI guideline standard: Normal left ventricular geometry, NG: LVMI≤115g/m2（male）or LVMI≤95g/m2（female）and RWT≤0.42 Concentric remodeling, CR: LVMI≤115g/m2（male）or LVMI≤95g/ m2（female）and RWT>0.42
Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing:
Normal left ventricular geometry, NG: LVMI≤108g/ m2（male）and RWT≤0.51 or LVMI≤99g/ m2（female）and RWT>0.49 Concentric remodeling, CR: LVMI≤108g/ m2（male）and RWT>0.51 or LVMI≤99g/ m2（female）and RWT>0.49 Receives: Other: Left ventricular non-hypertrophy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emerging atrial fibrillation
The differences in the incidence of atrial fibrillation between the two groups
Measured: Through study completion, on average once a year.
Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death
The differences in the incidence of unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death between the two groups
Measured: Through study completion, on average once a year.
Emerging transient ischemic attack (TIA) or stroke
The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups
Measured: Through study completion, on average once a year.
Secondary outcomes (5)
Emerging decreased cardiac function with preserved ejection fraction
The differences between the two groups in the incidence of decreased cardiac function with preserved ejection fraction measured by echocardiography compared to that at the baseline
Measured: Through study completion, on average once a year.
Emerging cardiac remodeling
The differences between the two groups in the incidence of cardiac remodeling measured by echocardiography compared to that at the baseline
Measured: Through study completion, on average once a year.
Emerging aortic aneurysm or aortic dissection
The differences in the incidence of aortic aneurysm or aortic dissection between the two groups
Measured: Through study completion, on average once a year.
Emerging serious arrhythmias
ECG showed that QTc (QT interval corrected by heart rate) was more than 500ms or QTc was longer than the baseline level for more than 60ms, emerging torsade de pointes ventricular tachycardia and other serious arrhythmias
Measured: Through study completion, on average once a year.
The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes
The differences between the two groups in the incidence of the deviations between blood pressure and cardiac function parameters at the same day measured by echocardiography
Measured: Through study completion, on average once a year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 May 2022
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei Zhang, PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638503
- Sponsor's protocol ID
- QLCR20220272
- Status last verified
- Apr 2024
- First submitted
- 15 Nov 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
- ClinicalTrials.gov ID
- NCT05638503
- Acronym / sponsor ID
- QLCR20220272
- Conditions
- Hypertension
- Keywords
- Hypertension, Echocardiography, Cardiovascular remodeling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Dec 2022 (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.
The investigators want to explore the relationship between different configurations of hypertension and the incidence of cardiovascular events by the guidelines reference range and EMINCA recommended reference range. Then the investigators want to enroll twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up. Echocardiographic measurement parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
Detailed description
Different configurations of hypertension are important risk factor for the morbidity and mortality of cardiovascular and cerebrovascular diseases in China. Studies have shown that left ventricular hypertrophy (LVH) and left atrial enlargement caused by hypertension are independent risk factors for cardiovascular events. The LVM and LAV derived from the normal value data of Chinese healthy adults have been reported to be different from the recommended reference values in guidelines, and the distribution characteristics of hypertension remodeling are also different. However, the characteristics and outcomes of cardiac remodeling in Chinese hypertensive population and whether this difference in configuration has an impact on the treatment, prognosis and cardiovascular events of hypertensive population are still needed to be explored.
This study was to observe the relationship between blood pressure and cardiovascular remodeling evaluated by different standards in hypertensive population, and compare the relationship between different cardiac configurations and cardiovascular events in Chinese hypertensive population.
Twenty research centers and 2200 hypertensions were planned to be collected and followed up in the 12th, 24th, 36th and 48th months after being enrolled in this study. Physical examination, ECG examination, laboratory examination, echocardiography and carotid ultrasound should be taken when baseline and follow-up.
Echocardiographic measurement parameters including M-mode and two-dimensional ultrasonic parameters; doppler ultrasound parameters; relevant parameters of two-dimensional speckle tracking, myocardial work parameters; the left ventricular remodeling parameters (LVM and RWT); cardiac morphological changes; three-dimensional ultrasound parameters were analyzed and the relationship between the echocardiographic measurement parameters and cardiovascular events and prognosis of hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension with left ventricular hypertrophy group | – | Other: Left ventricular hypertrophy2015 ASE/EACVI guideline standard: Eccentric hypertrophy, EH: LVMI>115g/ m2（male）or LVMI>95g/ m2（female）and RWT≤0.42 Concentric hypertrophy, CH: LVMI>115g/ m2（male）or LVMI>95g/ m2（female）and RWT>0.42 Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing: Eccentric hypertrophy, EH: LVMI>108g/ m2（male）and RWT≤0.51or LVMI>99g/ m2（female）and RWT≤0.49 Concentric hypertrophy, CH: LVMI>108g/ m2（male）and RWT>0.51 or LVMI>99g/ m2（female）and RWT>0.49 |
| Hypertension with left ventricular non-hypertrophy group | – | Other: Left ventricular non-hypertrophy2015 ASE/EACVI guideline standard: Normal left ventricular geometry, NG: LVMI≤115g/m2（male）or LVMI≤95g/m2（female）and RWT≤0.42 Concentric remodeling, CR: LVMI≤115g/m2（male）or LVMI≤95g/ m2（female）and RWT>0.42 Reference Values for Chinese (EMINCA) and Configuration Analysis Based on Ganau Typing: Normal left ventricular geometry, NG: LVMI≤108g/ m2（male）and RWT≤0.51 or LVMI≤99g/ m2（female）and RWT>0.49 Concentric remodeling, CR: LVMI≤108g/ m2（male）and RWT>0.51 or LVMI≤99g/ m2（female）and RWT>0.49 |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg
Key inclusion criteria (4 listed)
- Age 30-75 years old;
- No antihypertensive drugs were used and three blood pressure measurements were conducted on different days, with systolic blood pressure ≥ 140 mmHg (1 mmHg=0.133 kPa) and/or diastolic blood pressure ≥ 90 mmHg; or have a history of hypertension and are using antihypertensive drugs, even if the blood pressure is lower than 140/90 mmHg;
- Left ventricular ejection fraction was normal (LVEF ≥ 0.5).
- All patients agreed to participate in the experiment and signed the informed consent form.
Key exclusion criteria (6 listed)
- Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases;
- Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery;
- Abnormal liver function; abnormal renal function and diabetes;
- Pregnant or breastfeeding women;
- Expected survival time due to non-cardiovascular disease<4 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left ventricular hypertrophyHypertension with normal left ventricular geometry and left ventricular concentric remodeling | Other | Hypertension with left ventricular hypertrophy group |
| Left ventricular non-hypertrophyHypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy | Other | Hypertension with left ventricular non-hypertrophy group |
Primary outcome
Emerging atrial fibrillation
Time frame: Through study completion, on average once a year.
The differences in the incidence of atrial fibrillation between the two groups
Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death
Time frame: Through study completion, on average once a year.
The differences in the incidence of unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death between the two groups
Emerging transient ischemic attack (TIA) or stroke
Time frame: Through study completion, on average once a year.
The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups
5 secondary outcomes
Emerging decreased cardiac function with preserved ejection fraction
Time frame: Through study completion, on average once a year.
Emerging cardiac remodeling
Time frame: Through study completion, on average once a year.
Emerging aortic aneurysm or aortic dissection
Time frame: Through study completion, on average once a year.
Emerging serious arrhythmias
Time frame: Through study completion, on average once a year.
The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes
Time frame: Through study completion, on average once a year.
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 4 Apr 2024.
- 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.
Mei Zhang, PhD principal investigator
Qilu Hospital of Shandong University
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, run by Qilu Hospital of Shandong University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Apr 2024. 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?
Contact Mei Zhang, PhD (+86-18560086629, daixh@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emerging atrial fibrillation (time frame: Through study completion, on average once a year.). The study lists 3 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 4 Apr 2024.