NCT05841654

Effect of Azilsartan on Atrial Fibrillation in Patients With Hypertension

Effect of Azilsartan on the Incidence of Atrial Fibrillation in Patients With Hypertension Combined With Left Ventricular Hypertrophy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Beijing Tsinghua Chang Gung Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hypertension and atrial fibrillation (AF) are two major public health problems worldwide. Hypertension is an important risk factor for AF, and the combination of which could significantly increase the risk of cardiovascular adverse events, and result greater disability rate and mortality. Hypertension can stimulate cardiomyocytes apoptosis, drive renin-angiotensin-aldosterone system (RAAS) activation, lead to left ventricular hypertrophy (LVH) and finally result in the structure remodeling of the atrium, which can trigger AF development through influence on myocardial electrical activity. Previous studies have found that angiotensin receptor blockers (ARB) seem to be more efficient in preventing AF when hypertension combined heart failure or LVH, but not completely clear in others with hypertension. Azilsartan is a new ARB, it replaces the tetrazole ring of the traditional ARB with the oxadiazole ring, which making it binds to the angiotensin type 1 (AT1) receptor more tightly, dissociate more slowly, and has a stronger antihypertensive effect. It was reported that Azilsartan could inhibit cell proliferation, reduce inflammation and oxidative stress. However, whether Azilsartan can reduce the risk of AF in hypertensive patients, and the possible corresponding mechanism is still unclear. Accordingly, the investigators designed this study intending to evaluate the effect of Azilsartan on the incidence of AF in hypertensive patients combined with LVH, and to explore the possible mechanism. This study is a practical, multicenter randomized controlled research method, the investigators will include 400 patients with hypertension and LVH who meet the inclusion criteria in Beijing Tsinghua Changgung Hospital and other centers. The patients would be divided into the Azilsartan group and conventional treatment group randomly, and be followed up regularly for 12 months. The incidence of AF in the two groups would be compared through the flexible intelligent ECG monitoring system, and the optimal blood pressure control, also the left ventricular hypertrophy and left atrial function would be evaluated. This study will provide evidence for the use of Azilsartan in blood pressure control and lower risk for AF patients with hypertension and LVH. It will be benefit for improving prognosis of patients with hypertension combined LVH, reducing the incidence of AF, and achieving good social economic effects.

Conditions

• Hypertension
• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Azilsartan or antihypertensive drugs other than ACEI, ARB or ARNI	The patient's ECG information will be monitored through the ECG monitoring patch, and the time of the first atrial fibrillation event will be recorded. Monitoring whether the patient's blood pressure is controlled dynamically, using echocardiography to evaluate cardiac function, and using scales to assess the quality of life.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-06-01
• Completion: 2025-10-01
• First posted: 2023-05-03
• Last updated: 2023-05-03

Locations

1 site across 1 country: China