A Cohort Study of Telmisartan on Metabolic Components and Left Ventricular Remodeling in Obese Patients With Hypertension
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Heart failure
研究概览
简要总结
Hypertension is closely related to metabolic abnormalities such as obesity, dyslipidemia and diabetes. When hypertension is complicated with metabolic abnormalities, target organ damage is more serious, the risk of cardiovascular adverse events is greater, and the treatment is more complex. The pathophysiological mechanism of obesity-associated hypertension has its particularity. Blood pressure control and effective control of obesity are important therapeutic targets. At present, there are no guidelines for the treatment of obesity-associated hypertension. Although several drugs have certain effects on fat metabolism, they have little effect on blood pressure and have some side effects in long-term use. Among the existing antihypertensive drugs, angiotensin II type 1 receptor (AT-1) antagonists have shown their particularity in improving glycolipid metabolism, but strict clinical trials are needed to confirm their effectiveness in weight loss and metabolism improvement. Previous studies have shown that obese patients with hypertension have severe insulin resistance, poor glycolipid metabolism and are prone to cardiovascular damage. Telmisartan can block AT-1 receptor and partially activate PPAR-γ, increase the expression of PPAR-γ target gene in preadipocytes, improve the function of visceral adipose tissue, and effectively prevent obesity-related cardiovascular diseases. It is presumed that telmisartan can act as a PPAR-γ agonist in clinic by altering the metabolic components and insulin sensitivity, but there is no clinical evidence for this. On the basis of previous studies, this study aims to evaluate the clinical efficacy of telmisartan or amlodipine in controlling blood pressure, reducing fat accumulation, improving insulin sensitivity, and reducing cardiac remodeling in obese patients with hypertension by prospective cohort study.
详细描述
At present, there are no guidelines for the treatment of obese patients with hypertension. Blood pressure control and effective control of obesity are important therapeutic targets for obesity-associated hypertension. Whether telmisartan can be used as PPAR-γ agonist, unlike other AT-1 receptor antagonists and calcium channel blockers amlodipine, can improve the visceral adipose tissue function and cardiac remodeling in obese patients with hypertension by altering their metabolic components and insulin sensitivity while controlling blood pressure. There is no evidence that telmisartan can reduce cardiac remodeling in obese patients with hypertension.
1.Research contents:
- To evaluate the clinical efficacy of telmisartan or amlodipine in controlling blood pressure, reducing fat accumulation, improving glycolipid metabolism and insulin sensitivity, and reducing cardiac remodeling in obese patients with hypertension;
- To evaluate whether telmisartan can alter metabolic components and insulin sensitivity, improve visceral adipose tissue function and reduce cardiac remodeling in obese patients with hypertension by blocking AT-1 receptor and partially activating PPAR-gamma, which is different from other AT-1 receptor antagonists and calcium channel blockers amlodipine.
2.Research population 2.1 Entry criteria
Only those who possess the following four conditions can enter the study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Essential hypertension patients (including those with unconventional diagnosed hypertension, whose average blood pressure was more than 160 or/and 100 mmHg in two outpatient follow-up visits; or those who were undergoing combined antihypertensive therapy; or those whose blood pressure control was unsatisfactory and whose blood pressure was more than 140 or/and 90 mmHg in single drug treatment);
- •The age ranged from 18 to 79 years;
- •Body mass index, BMI (≥ 30 kg/m2), or waist circumference, male (≥102 cm), female (≥88 cm);
- •Ability to provide informed consent.
排除标准
- •Secondary hypertension;
- •Acute cardiovascular and cerebrovascular events occurred within 3 months;
- •Complicated with severe cardiomyopathy, rheumatic heart disease, congenital heart disease;
- •unstable angina pectoris;
- •Severe liver or kidney diseases (ALT increased twice; creatinine > 2.5 mg/d1);
- •Women who are taking contraceptives or are at risk of pregnancy; -Has a history of allergy to research drugs;
- •Those who have clear contraindications to the research drugs;
- •Those who are participating in other clinical trials;
- •Those who are not easy to follow up for a long time or have poor compliance;
- •Doctors in charge do not consider it advisable to participate in clinical research.
研究组 & 干预措施
Telmisartan
generic name：telmisartan；dosage form：80 mg；dosage：80 mg；frequency：once a day；duration：June , 2019-June , 2021
干预措施: telmisartan (Drug)
Amlodipine
generic name： amlodipine；dosage form：5mg；dosage：5mg；frequency：once a day；duration：June , 2019-June , 2021
干预措施: amlodipine (Drug)
结局指标
主要结局
Heart failure
时间窗: From date of randomization until the date of first documented progression，assessed up to 24 months
Heart failure
stroke
时间窗: From date of randomization until the date of first documented progression，assessed up to 24 months
stroke
Revascularization for myocardial infarction and unstable angina pectoris
时间窗: From date of randomization until the date of first documented progression，assessed up to 24 months
Revascularization for myocardial infarction and unstable angina pectoris
次要结局
未报告次要终点