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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.
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:
2.Research population 2.1 Entry criteria
Only those who possess the following four conditions can enter the study:
2.2 exclusion criteria
One of the following is not included:
(1) secondary hypertension; (2) acute cardiovascular and cerebrovascular events within 3 months; (3) severe cardiomyopathy, rheumatic heart disease, congenital heart disease;(4) unstable angina pectoris; (5) severe liver or kidney disease (ALT increased by 2 times; Creatinine > 2. 5 mg/dL); (6) malignant tumors; (7) gout; (8) women who are taking birth control pills or are at risk of pregnancy; (9) have a history of allergy to research drugs; (10) patients with specific contraindications to the study drugs; (11) participants in other clinical trials; (12) patients with difficulty in long-term follow-up or poor compliance; (13) the competent doctor considers it inappropriate to participate in clinical research.
3.The input information of the subjects
4.Criteria for termination or withdrawal of research subjects
5. Study Groups
6.Research evaluation index
7.Research steps
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telmisartan | Experimental | generic name:telmisartan;dosage form:80 mg;dosage:80 mg;frequency:once a day;duration:June , 2019-June , 2021 |
|
| Amlodipine | Active Comparator | generic name: amlodipine;dosage form:5mg;dosage:5mg;frequency:once a day;duration:June , 2019-June , 2021 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telmisartan | Drug | Telmisartan group: telmisartan 80 mg once a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Heart failure | Heart failure | From date of randomization until the date of first documented progression,assessed up to 24 months |
| stroke | stroke | From date of randomization until the date of first documented progression,assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Tian, doctor | Contact | 0086-18991232420 | tiangang@xjtu.edu.cn | |
| Lifei Cao, master | Contact | 0086-15829315817 | caolifei1187@stu.xjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Gang Tian, doctor | First Affiliated Hospital Xi'an Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D000077333 | Telmisartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| amlodipine |
| Drug |
amlodipine group: amlodipine 5 mg once a day |
|
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |