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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJing Huang

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • External Ultrasonic Micro-bubble

    Device

    The enrollmented hypertensive patients should aceepted CB modulation therapy by external ultrasonic micro-bubble

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Health volunteersOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

The control rate of hypertension at 6 month

The investigators would evaluate the control rate of hypertension at 6 month after CB modulation therapy.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months
3

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.

Time frame
6 months
4

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.

Time frame
6 months

Other outcomes

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: