NCT06116357

The Safety and Efficacy of Carotid Body Modulation Therapy in Hypertensive Patients by External Ultrasonic Micro-bubble

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Jing Huang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The investigators intend to find a noninvasive method for CB modulation therapy and find a simple and convenient indicator for assessing CB activity. This study was designed to evaluate the safety and efficacy of carotid body modulation therapy in hypertensive patients by external ultrasonic micro-bubble and also identify the association between CB volume and CB activity.

Detailed description

Carotid body (CB) hyperactivity, with excessive afferent discharge signal to the respiratory centre anautonomic sympathetic nuclei, can result in hyperventilation and sympathetic hyperactivity. And previous studies have found that CB hyperactivity was common in several kinds of cardiovascular diseases and the investigators also found that CB was obviously enlargement in hypertension and other cardiovascular diseases. Hence, CB might play an important role in the development of these cardiovascular diseases. Moreover, Resection of CB or blockade of P2X3 receptors in CB significantly reduced blood pressure (BP) and muscle sympathetic nerve activity (MSNA) in patients with hypertension. Therefore, CB may be a promising therapeutic target for hypertension. However, the following questions about CB are needed to be addressed urgently. First, the CB volume enlargement may be a promising indicator for selection appropriate patients for CB modulation therapy, but its relationship with the CB hyperactivity is still unclear. Second, although CB resection could significantly reduce BP in hypertensive patients, but the invasive therapy and completely resection may result in severe adverse events. Based on the aforementioned questions, to find a simple and convenient indicator for assessing CB activity and find a noninvasive method for CB modulation therapy, the investigators designed this study to identify the association between CB volume and CB activity in hypertensive patients and also evaluated the safety and efficacy of carotid body modulation therapy in hypertensive patients by external ultrasonic micro-bubble.

Conditions

• Primary Hypertension

Interventions

Type	Name	Description
DEVICE	External Ultrasonic Micro-bubble	The enrollmented hypertensive patients should aceepted CB modulation therapy by external ultrasonic micro-bubble

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-09-01
• Completion: 2026-12-30
• First posted: 2023-11-03
• Last updated: 2023-11-03

Locations

1 site across 1 country: China