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

NCT03956823 | Unknown

• 1 other identifier: XJTU1AF-CRF-2018-005
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

hypertension; obesity; telmisartan; metabolic abnormalities; cardiac remodeling

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Telmisartan

EXPERIMENTAL

generic name：telmisartan；dosage form：80 mg；dosage：80 mg；frequency：once a day；duration：June , 2019-June , 2021

Drug: telmisartan

Amlodipine

ACTIVE COMPARATOR

generic name： amlodipine；dosage form：5mg；dosage：5mg；frequency：once a day；duration：June , 2019-June , 2021

Drug: amlodipine

Interventions

telmisartan DRUG

Telmisartan group: telmisartan 80 mg once a day

Telmisartan

amlodipine DRUG

amlodipine group: amlodipine 5 mg once a day

Amlodipine

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Hypertension; Obesity

Interventions

Telmisartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gang Tian, doctor

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Tian, doctor

CONTACT

0086-18991232420; tiangang@xjtu.edu.cn

Lifei Cao, master

CONTACT

0086-15829315817; caolifei1187@stu.xjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 21, 2019
• Study Start: August 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 8, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)