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

NCT06116357 | Not Yet Recruiting

• 1 other identifier: 2023-78
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hypertension

Keywords

Carotid body modulation therapy; Hypertension; Carotid body activity; Carotid body volume; Ultrasonic micro-bubble

Outcome Measures

Primary Outcomes (3)

• 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.

  6 months

• 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.

  6 months

• The control rate of hypertension at 6 month

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

  6 months

Secondary Outcomes (8)

• The change from baseline CB activity at 6months

  6 months

• The change from baseline CB volume at 6months

  6 months

• The change from baseline 24-hour mean ambulatory DBP at 6 months

  6 months

• The change from baselines office SBP and DBP at 6 months

  6 months

• The incidence of CB modulation therapy associated adverse events including MACE events, hypotension, carotid artery stenosis and hyoxemia at 6 months

  6 months

Study Arms (1)

Health volunteers

OTHER

Evaluate the CB activity of health volunteers as the control

Device: External Ultrasonic Micro-bubble

Interventions

External Ultrasonic Micro-bubble DEVICE

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

Health volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• hour ambulatory systolic blood pressure: ≥135 mmHg and \<170 mmHg
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Huang: lead
• The Second Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

The Second Affilated Hospital of Chongqing Medical Universty

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (5)

• Xue Q, Wang R, Wang L, Xiong B, Li L, Qian J, Hao L, Wang Z, Liu D, Deng C, Rong S, Yao Y, Jiang Y, Zhu Q, Huang J. Downregulating the P2X3 receptor in the carotid body to reduce blood pressure via acoustic gene delivery in canines. Transl Res. 2021 Jan;227:30-41. doi: 10.1016/j.trsl.2020.06.005. Epub 2020 Jun 14.

  PMID: 32554072 BACKGROUND

• Del Rio R, Marcus NJ, Schultz HD. Carotid chemoreceptor ablation improves survival in heart failure: rescuing autonomic control of cardiorespiratory function. J Am Coll Cardiol. 2013 Dec 24;62(25):2422-2430. doi: 10.1016/j.jacc.2013.07.079. Epub 2013 Sep 4.

  PMID: 24013056 BACKGROUND

• Iturriaga R, Del Rio R, Idiaquez J, Somers VK. Carotid body chemoreceptors, sympathetic neural activation, and cardiometabolic disease. Biol Res. 2016 Feb 26;49:13. doi: 10.1186/s40659-016-0073-8.

  PMID: 26920146 BACKGROUND

• Niewinski P, Janczak D, Rucinski A, Tubek S, Engelman ZJ, Piesiak P, Jazwiec P, Banasiak W, Fudim M, Sobotka PA, Javaheri S, Hart EC, Paton JF, Ponikowski P. Carotid body resection for sympathetic modulation in systolic heart failure: results from first-in-man study. Eur J Heart Fail. 2017 Mar;19(3):391-400. doi: 10.1002/ejhf.641. Epub 2016 Sep 20.

  PMID: 27647775 BACKGROUND

• Tan J, Xiong B, Zhu Y, Yao Y, Qian J, Rong S, Yang G, Zhu Q, Jiang Y, Zhou Q, Liu D, Deng C, Ran H, Wang Z, He T, Huang J. Carotid body enlargement in hypertension and other comorbidities evaluated by ultrasonography. J Hypertens. 2019 Jul;37(7):1455-1462. doi: 10.1097/HJH.0000000000002068.

  PMID: 30925145 RESULT

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jing Huang, MD

  The Second Affiliated Hospital of Chongqing Medcial University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Lu, PhD

CONTACT

0086-023-63693099; kyc1892@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Model Details: primary hypertensive patients

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)