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Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension

Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05638503
Enrollment
2200
Registered
2022-12-06
Start date
2022-05-01
Completion date
2027-12-31
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Echocardiography, Cardiovascular remodeling

Brief 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. 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.

Interventions

OTHERLeft ventricular hypertrophy

Hypertension with normal left ventricular geometry and left ventricular concentric remodeling

OTHERLeft ventricular non-hypertrophy

Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age 30-75 years old; 2. 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; 3. Left ventricular ejection fraction was normal (LVEF ≥ 0.5). 4. All patients agreed to participate in the experiment and signed the informed consent form.

Exclusion criteria

1. Secondary hypertension caused by renal parenchymal diseases, renal vascular diseases, coarctation of aorta and endocrine system diseases; 2. Severe cardiovascular and cerebrovascular diseases; heart valve disease; persistent atrial fibrillation and severe arrhythmia; previously undergone cardiovascular disease surgery; 3. Abnormal liver function; abnormal renal function and diabetes; 4. Pregnant or breastfeeding women; 5. Expected survival time due to non-cardiovascular disease\<4 years; 6. Patients with poor echocardiographic image quality.

Design outcomes

Primary

MeasureTime frameDescription
Emerging atrial fibrillationThrough 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 deathThrough 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 strokeThrough study completion, on average once a year.The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups

Secondary

MeasureTime frameDescription
Emerging serious arrhythmiasThrough study completion, on average once a year.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
Emerging decreased cardiac function with preserved ejection fractionThrough study completion, on average once a year.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
The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexesThrough study completion, on average once a year.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
Emerging cardiac remodelingThrough study completion, on average once a year.The differences between the two groups in the incidence of cardiac remodeling measured by echocardiography compared to that at the baseline
Emerging aortic aneurysm or aortic dissectionThrough study completion, on average once a year.The differences in the incidence of aortic aneurysm or aortic dissection between the two groups

Countries

China

Contacts

Primary ContactMei Zhang, PhD
daixh@vip.sina.com+86-18560086629
Backup ContactYu Zhang, PhD
zhangyu_505@126.com+86-18560088296

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026