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

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ClinicalTrials.gov Identifier: NCT03956823
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: telmisartan Drug: amlodipine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Cohort Study of Telmisartan on Metabolic Components and Left Ventricular Remodeling in Obese Patients With Hypertension
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Telmisartan
generic name:telmisartan;dosage form:80 mg;dosage:80 mg;frequency:once a day;duration:June , 2019-June , 2021
Drug: telmisartan
Telmisartan group: telmisartan 80 mg once a day

Active Comparator: Amlodipine
generic name: amlodipine;dosage form:5mg;dosage:5mg;frequency:once a day;duration:June , 2019-June , 2021
Drug: amlodipine
amlodipine group: amlodipine 5 mg once a day




Primary Outcome Measures :
  1. Revascularization for myocardial infarction and unstable angina pectoris [ Time Frame: From date of randomization until the date of first documented progression,assessed up to 24 months ]
    Revascularization for myocardial infarction and unstable angina pectoris

  2. Heart failure [ Time Frame: From date of randomization until the date of first documented progression,assessed up to 24 months ]
    Heart failure

  3. stroke [ Time Frame: From date of randomization until the date of first documented progression,assessed up to 24 months ]
    stroke



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03956823


Contacts
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Contact: Gang Tian, doctor 0086-18991232420 tiangang@xjtu.edu.cn
Contact: Lifei Cao, master 0086-15829315817 caolifei1187@stu.xjtu.edu.cn

Locations
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China, Shanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shanxi, China, 710061
Contact: Gang Tian, doctor    0086-18991232420    tiangang@xjtu.edu.cn   
Contact: Lifei Cao, master    0086-15829315817    caolifei1187@stu.xjtu.edu.cn   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Principal Investigator: Gang Tian, doctor First Affiliated Hospital Xi'an Jiaotong University

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03956823     History of Changes
Other Study ID Numbers: XJTU1AF-CRF-2018-005
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
hypertension
obesity
telmisartan
metabolic abnormalities
cardiac remodeling

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Telmisartan
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists