Primary HypertensionNCT06116357
The Safety and Efficacy of Carotid Body Modulation Therapy in Hypertensive Patients by External Ultrasonic Micro-bubble
A study testing External Ultrasonic Micro-bubble in people with Primary Hypertension, run by Jing Huang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Hypertension
- What is being tested?
- External Ultrasonic Micro-bubble
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- <!-- -->
- 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.
Who cannot join
- 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
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affilated Hospital of Chongqing Medical Universty
Chongqing, Chongqing Municipality, 400010
Jing Huang, MD, 0086-13508312022, drhj@aliyun.com, huangjing@cqmu.edu.cn
Jing Huang, MD
About this study
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.
Read the 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
- Being tested
- External Ultrasonic Micro-bubble
- Keywords
- Carotid body modulation therapy, Hypertension, Carotid body activity, Carotid body volume, Ultrasonic micro-bubble
- Medical subject headings
- Essential Hypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Ultrasonic Micro-bubbleDevice
The enrollmented hypertensive patients should aceepted CB modulation therapy by external ultrasonic micro-bubble
| Study group | Role | What they receive |
|---|---|---|
| Health volunteers | Other | Evaluate the CB activity of health volunteers as the control Receives: Device: External Ultrasonic Micro-bubble |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
The incidence of CB modulation therapy associated adverse events including MACE events, hypotension, carotid artery stenosis and hyoxemia at 6 months
The investigators would evaluate the incidence of CB modulation therapy associated adverse events including MACE events, hypotension, carotid artery stenosis and hyoxemia at 6 months after CB modulation therapy.
Measured: 6 months
The differences of CB volume between healthy volunteers and hypertension patients
The investigators would evaluate the differences of CB volume between healthy volunteers and hypertension patients at baselines.
Measured: at baseline
The differences of CB activity between healthy volunteers and hypertension patients
The investigators would evaluate the differences of CB activity between healthy volunteers and hypertension patients at baselines.
Measured: at baseline
The correlation analysis of heart rate variability and CB activity in hypertension patients at baseline
The investigators would evaluate the association between heart rate variability and CB activity in hypertension patients at baseline.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- primary hypertensive patients
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Huang
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Responsible party
- Sponsor-investigator, Jing Huang, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Jing Huang, MD, Principal investigator, The Second Affiliated Hospital of Chongqing Medcial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116357
- Sponsor's protocol ID
- 2023-78
- Status last verified
- Oct 2023
- First submitted
- 19 Jun 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We may share the IPD when the study was completely finished.
Publications
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.
PubMed 32554072Del 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.
PubMed 24013056Iturriaga 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.
PubMed 26920146Niewinski 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.
PubMed 27647775Tan 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.
PubMed 30925145
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Carotid Body Modulation Therapy in Hypertensive Patients by External Ultrasonic Micro-bubble
- ClinicalTrials.gov ID
- NCT06116357
- Acronym / sponsor ID
- 2023-78
- Conditions
- Primary Hypertension
- Keywords
- Carotid body modulation therapy, Hypertension, Carotid body activity, Carotid body volume, Ultrasonic micro-bubble
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jing HuangUniversity, hospital or other
- Collaborators
- The Second Affiliated Hospital of Chongqing Medical University
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- primary hypertensive patients
| Arm | Type | Receives |
|---|---|---|
| Health volunteers | Other | Device: External Ultrasonic Micro-bubbleEvaluate the CB activity of health volunteers as the control |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Hypertensive patients for CB modulation therapy
- 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
- <!-- -->
Key exclusion criteria (28 listed)
- Hypertensive patients for CB modulation therapy
- Patients for CB Volume and activity evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Ultrasonic Micro-bubbleThe enrollmented hypertensive patients should aceepted CB modulation therapy by external ultrasonic micro-bubble | Device | Health volunteers |
Primary outcome
The change from baseline 24-hour mean ambulatory SBP at 6 months
Time frame: 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
Time frame: 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
Time frame: 6 months
The investigators would evaluate the control rate of hypertension at 6 month after CB modulation therapy.
8 secondary outcomes
The change from baseline CB activity at 6months
Time frame: 6 months
The change from baseline CB volume at 6months
Time frame: 6 months
The change from baseline 24-hour mean ambulatory DBP at 6 months
Time frame: 6 months
The change from baselines office SBP and DBP at 6 months
Time frame: 6 months
The incidence of CB modulation therapy associated adverse events including MACE events, hypotension, carotid artery stenosis and hyoxemia at 6 months
Time frame: 6 months
The differences of CB volume between healthy volunteers and hypertension patients
Time frame: at baseline
The differences of CB activity between healthy volunteers and hypertension patients
Time frame: at baseline
The correlation analysis of heart rate variability and CB activity in hypertension patients at baseline
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Background: PubMed 32554072Xue 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.
- Background: PubMed 24013056Del 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.
- Background: PubMed 26920146Iturriaga 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.
- Background: PubMed 27647775Niewinski 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.
- Results publication: PubMed 30925145Tan 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.
- Individual participant dataSharing planned: No. We may share the IPD when the study was completely finished.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Huang, MD principal investigator
The Second Affiliated Hospital of Chongqing Medcial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External Ultrasonic Micro-bubble in people with Primary Hypertension, run by Jing Huang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Lu, PhD (0086-023-63693099, kyc1892@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline 24-hour mean ambulatory SBP at 6 months (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06116357, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.