Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension | Drug: telmisartan Drug: amlodipine | Not Applicable |
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 |
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
|
Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gang Tian, doctor | 0086-18991232420 | tiangang@xjtu.edu.cn | |
Contact: Lifei Cao, master | 0086-15829315817 | caolifei1187@stu.xjtu.edu.cn |
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 |
Principal Investigator: | Gang Tian, doctor | First Affiliated Hospital Xi'an Jiaotong University |
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date ICMJE | May 4, 2019 | ||||||||
First Posted Date ICMJE | May 21, 2019 | ||||||||
Last Update Posted Date | August 8, 2019 | ||||||||
Actual Study Start Date ICMJE | August 1, 2019 | ||||||||
Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
|
||||||||
Original Primary Outcome Measures ICMJE |
|
||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Clinical Efficacy of Telmisartan in Reducing Cardiac Remodeling Among Obese Patients With Hypertension | ||||||||
Official Title ICMJE | A Cohort Study of Telmisartan on Metabolic Components and Left Ventricular Remodeling in Obese Patients With Hypertension | ||||||||
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. | ||||||||
Detailed Description |
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
|
||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment |
||||||||
Condition ICMJE | Hypertension | ||||||||
Intervention ICMJE |
|
||||||||
Study Arms ICMJE |
|
||||||||
Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
300 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 1, 2021 | ||||||||
Estimated Primary Completion Date | May 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Sex/Gender ICMJE |
|
||||||||
Ages ICMJE | 18 Years to 79 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
|
||||||||
Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03956823 | ||||||||
Other Study ID Numbers ICMJE | XJTU1AF-CRF-2018-005 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
|
||||||||
IPD Sharing Statement ICMJE |
|
||||||||
Responsible Party | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Study Sponsor ICMJE | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
|
||||||||
PRS Account | First Affiliated Hospital Xi'an Jiaotong University | ||||||||
Verification Date | August 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |