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

Other illness

• Patients for CB Volume and activity evaluation
  • the CB could not be detected by carotid ultrasound or MRI.
  • The patients have secondary hypertension, heart failure.
  • The patients have type 1diabetes mellitus, CB tumor.
  • The patients were diagnosed as OSAS.
  • The patients have severe chronic constructive pulmonary disease, interstitial lung disease or other severe lung diseases.
  • Women who are pregnant, breastfeeding, or planning to become pregnant.
  • Patients with other conditions which are not appropriate for enrollment judged by the investigators.

Lab values

• 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.
  • Carotid ulcer.
  • Severe tortuosity of carotid artery
  • After carotid artery stenting or stripping
  • Other conditions that are not suitable for carotid intervention
  • Glomerular filtration rate (eGFR) \<45 mL/min / 1.73 m2
  • Have type 1 diabetes or poorly controlled type 2 diabetes (defined as plasma HbA1c≥ 9.0% or 24-hour urinary protein quantity \>1g/24h or proliferative retinal lesions)
  • postural hypotension.
  • Recent vascular events: Experienced acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months of the screening period.
  • Suspected secondary hypertension.
  • Respiratory support: The individual requires long-term oxygen support or mechanical ventilation (except for nighttime breathing support only because of sleep apnea).
  • Life expectancy \<1 year.
  • A woman who is pregnant, breastfeeding, or planning to become pregnant.
  • Subjects who are currently enrolled in another clinical trial and have not completed the primary endpoint.
  • Allergic to contrast media.
  • The investigators judged the patients' poor compliance and other reasons for not being suitable for participants in the trial.
  • Any other conditions that the investigator did not consider appropriate to participate in the trial.

• 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.
  • 2.24-hour ambulatory systolic blood pressure: ≥135 mmHg and \<170 mmHg
  • 3.A history of primary hypertension was recorded. 4.Patients who can understand the purpose of the trial, voluntarily participate and sign informed consent, and are willing to cooperate with clinical follow-up
• 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.
  • The office blood pressure of patients ≥ 140/90 mmHg; the patents were diagnosed hypertension and are taking anti-hypertensive drugs could also include, although the office blood pressure \< 140/90 mmHg.
  • The CB could be detected by carotid ultrasound or MRI. Control group
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  • The volunteers agree to take part in this study and perform CB MRI, ultrasound, CB activity tests and sign the informed consent.
  • The volunteers are healthy.