Hypertension Clinical Trial
Official title:
A Cohort Study of Telmisartan on Metabolic Components and Left Ventricular Remodeling in Obese Patients With Hypertension
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 79 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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); - Tumor; - Gout; - 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. |
Country | Name | City | State |
---|---|---|---|
China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital Xi'an Jiaotong University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Revascularization for myocardial infarction and unstable angina pectoris | Revascularization for myocardial infarction and unstable angina pectoris | From date of randomization until the date of first documented progression,assessed up to 24 months | |
Primary | Heart failure | Heart failure | From date of randomization until the date of first documented progression,assessed up to 24 months | |
Primary | stroke | stroke | From date of randomization until the date of first documented progression,assessed up to 24 months |
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