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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Emerging atrial fibrillation [Срок оценки: Through study completion, on average once a year.]
• Emerging unstable angina, myocardial infarction, heart failure, coronary revascularization, cardiovascular death [Срок оценки: Through study completion, on average once a year.]
• Emerging transient ischemic attack (TIA) or stroke [Срок оценки: Through study completion, on average once a year.]

Вторичные конечные точки (5)

• Emerging decreased cardiac function with preserved ejection fraction [Срок оценки: Through study completion, on average once a year.]
• Emerging cardiac remodeling [Срок оценки: Through study completion, on average once a year.]
• Emerging aortic aneurysm or aortic dissection [Срок оценки: Through study completion, on average once a year.]
• Emerging serious arrhythmias [Срок оценки: 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 [Срок оценки: Through study completion, on average once a year.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qilu Hospital of Shandong University — Цзинань

Идентификаторы

NCT: NCT05638503 · QLCR20220272

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗