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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638503
• Other study ID #: QLCR20220272
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2024
• Source: Qilu Hospital of Shandong University
• Contact: Mei Zhang, PhD
• Phone: +86-18560086629
• Email: daixh[@]vip.sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: December 31, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• Left ventricular hypertrophy
Hypertension with normal left ventricular geometry and left ventricular concentric remodeling
• Left ventricular non-hypertrophy
Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emerging atrial fibrillation	The differences in the incidence of atrial fibrillation between the two groups	Through study completion, on average once a year.
Primary	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	Through study completion, on average once a year.
Primary	Emerging transient ischemic attack (TIA) or stroke	The differences in the incidence of transient ischemic attack (TIA) or stroke between the two groups	Through study completion, on average once a year.
Secondary	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	Through study completion, on average once a year.
Secondary	Emerging cardiac remodeling	The differences between the two groups in the incidence of cardiac remodeling measured by echocardiography compared to that at the baseline	Through study completion, on average once a year.
Secondary	Emerging aortic aneurysm or aortic dissection	The differences in the incidence of aortic aneurysm or aortic dissection between the two groups	Through study completion, on average once a year.
Secondary	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	Through study completion, on average once a year.
Secondary	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	Through study completion, on average once a year.