Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05638503

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

Lijuan Bu, PhD

CONTACT

[email protected]

+86-18560088816

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Left ventricular hypertrophy

Other

Hypertension with normal left ventricular geometry and left ventricular concentric remodeling

Left ventricular non-hypertrophy

Other

Hypertension with left ventricular concentric hypertrophy and left ventricular eccentric hypertrophy

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Emerging decreased cardiac function with preserved ejection fraction

    Time frame: Through 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

  2. Emerging cardiac remodeling

    Time frame: Through 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

  3. Emerging aortic aneurysm or aortic dissection

    Time frame: Through study completion, on average once a year.

    The differences in the incidence of aortic aneurysm or aortic dissection between the two groups

  4. Emerging serious arrhythmias

    Time frame: Through 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

  5. 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.

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Zhang, PhD

CONTACT

[email protected]

+86-18560086629

Yu Zhang, PhD

CONTACT

[email protected]

+86-18560088296

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Dec 6, 2022
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.