Clinical Efficacy of Telmisartan in Reducing Cardiac Remodeling Among Obese Patients With Hypertension

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:

1. 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;
2. 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:

1. Essential hypertension patients (including confirmed hypertension without regular treatment, average blood pressure (≥160 or/and 100 mmHg) in two follow-up visits; or hypertension under combined antihypertensive treatment; or unsatisfactory blood pressure control with single drug treatment, blood pressure above 140 or/and 90 mmHg)；
2. Age ranges from 18 to 79；
3. Body mass index, BMI (≥30 kg/m2), or waist circumference, male (≥102 cm), female (≥ 88 cm)；
4. Ability to provide informed consent。

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

1. Sample source: Since December 2018, patients with essential hypertension were diagnosed in the First Affiliated Hospital of Xi'an Jiaotong University and treated with telmisartan or amlodipine alone under the guidance of doctors；
2. Recruitment procedures: selecting the subjects according to inclusion and exclusion criteria, and signing informed consent.

4.Criteria for termination or withdrawal of research subjects

1. Those who need revascularization because of myocardial infarction and unstable angina pectoris;
2. Heart failure;
3. Stroke.
4. Study Groups
5. Telmisartan group: Telmisartan 80 mg once a day
6. amlodipine group: amlodipine 5 mg once a day

6.Research evaluation index

1. Baseline indicators: age, sex, occupation, height, weight, BMI, waist-hip circumference, systolic blood pressure, diastolic blood pressure, heart rate;
2. Metabolic indicators: blood lipid, liver function, kidney function, oral glucose tolerance test, simultaneous insulin release test, plasma Glucagon, plasma aldosterone, plasma angiotensin II, abdominal fat distribution
3. Fat function: serum leptin, serum adiponectin, serum TNFalpha, serum IL-6, serum hs-CRP, serum PPAR-γ;
4. Cardiac remodeling: echocardiographic parameters .

7.Research steps

1. Clinical trials are ethically reviewed by ethics committees, and clinical trials are registered;
2. Collect cases according to inclusion and exclusion criteria, collect medical history data of subjects, and complete follow-up. At the same time, clinical and biochemical experiments were carried out;
3. Comprehensive analysis of experimental data, repetition and supplementation of necessary molecular biological experiments, comprehensive summary of the results, writing and publishing SCI papers and Chinese core journal papers.