Clinical trial NCT05638503: Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
Official title: Multi-center Study on New Cardiovascular Remodeling and Function Parameters in Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Hypertension
Echocardiography
Cardiovascular remodeling
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 2200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emerging atrial fibrillation
timeFrame: Through study completion, on average once a year.
measure: Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death
timeFrame: Through study completion, on average once a year.
measure: Emerging transient ischemic attack (TIA) or stroke
timeFrame: Through study completion, on average once a year.
Secondary outcomes:
measure: Emerging decreased cardiac function with preserved ejection fraction
timeFrame: Through study completion, on average once a year.
measure: Emerging cardiac remodeling
timeFrame: Through study completion, on average once a year.
measure: Emerging aortic aneurysm or aortic dissection
timeFrame: Through study completion, on average once a year.
measure: Emerging serious arrhythmias
timeFrame: Through study completion, on average once a year.
measure: The relationship between the deviations of blood pressure within the same day and the difference of cardiac function indexes
timeFrame: Through study completion, on average once a year.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Mei Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: