About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hypertensive patients for CB modulation therapy
Two or more antihypertensive medications that had been prescribed at least 50% of the manufacturer's maximum dose for at least 2 consecutive weeks before study; Patients take an angiotensin-converting enzyme inhibitor (ACEI) (or angiotensin-ⅱ receptor antagonist (ARB)) and calcium channel blocker (CCB) (or thiazide diuretic) ; Office systolic blood pressure (SBP)≥150 mmHg and <180mmHg.
Patients for CB Volume and activity evaluation Hypertension group
Primary hypertension patients agrees to take part in this study and perform CB MRI, ultrasound, CB activity tests and sign the informed consent.
Disqualifiers
Hypertensive patients for CB modulation therapy
Carotid body anatomy is not eligible for treatment: ultrasound examination before treatment fail to find carotid body at carotid artery bifurcation.
Carotid body anatomical heterotopic is difficult to select or unsuitable for ultrasound irradiation.
Carotid anatomy that does not meet treatment conditions: severe carotid stenosis or occlusion.
Trial design
Single group
Treatments tested in this trial
External Ultrasonic Micro-bubble
DeviceThe enrollmented hypertensive patients should aceepted CB modulation therapy by external ultrasonic micro-bubble
Treatment groups
Trial outcomes
Primary outcomes
The change from baseline 24-hour mean ambulatory SBP at 6 months
The investigators would evaluate the change from baseline 24-hour mean ambulatory SBP at 6 months after CB modulation therapy.
The change from baseline daytime mean ambulatory SBP at 6 months
The investigators would evaluate the change from baseline daytime mean ambulatory SBP at 6 months after CB modulation therapy.
The control rate of hypertension at 6 month
The investigators would evaluate the control rate of hypertension at 6 month after CB modulation therapy.
Secondary outcomes
The change from baseline CB activity at 6months
The investigators would evaluate the change from baseline CB activity at 6months in hypertension patients after CB modulation therapy.
The change from baseline CB volume at 6months
The investigators would evaluate the change from baseline CB volume at 6months in hypertension patients after CB modulation therapy.
The change from baseline 24-hour mean ambulatory DBP at 6 months
The investigators would evaluate the change from baseline 24-hour mean ambulatory DBP at 6 months after CB modulation therapy.
The change from baselines office SBP and DBP at 6 months
The investigators would evaluate the change from baselines office SBP and DBP at 6 months after CB modulation therapy.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jing Huang
Lead sponsor
The Second Affiliated Hospital of Chongqing Medical University
Sponsor institution
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options: