NCT03956823

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

Status unknown NA Last updated 8 August 2019

What this trial tests

NA trial testing telmisartan in Hypertension in 300 participants. Status unknown.

Timeline

1 August 2019

Primary endpoint
1 May 2021

1 December 2021

Quick facts

Lead sponsor	First Affiliated Hospital Xi'an Jiaotong University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	300
Start date	1 August 2019
Primary completion	1 May 2021
Estimated completion	1 December 2021
Sites	1 location across China

Drugs / interventions tested

• telmisartan (TELMISARTAN) — full drug profile →
• amlodipine (amlodipine) — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Who can join

Adults 18 to 79, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Post-myocardial infarction fibrosis: Pathophysiology, examination, and intervention.
   Yin X, Yin X, Pan X, Zhang J, et al · · 2023 · cited 50× · PMID 37056987 · DOI 10.3389/fphar.2023.1070973