Not Yet RecruitingNot Applicable

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

China200 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓.24-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
✓. 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
✓. 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.

Exclusion criteria

✕. Carotid body anatomy is not eligible for treatment: ultrasound examination before treatment fail to find carotid body at carotid artery bifurcation.

What they're measuring

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

Timeframe: 6 months

The change from baseline daytime mean ambulatory SBP at 6 months

Timeframe: 6 months

The control rate of hypertension at 6 month

Timeframe: 6 months

Trial details

NCT IDNCT06116357

SponsorJing Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-01

Contact for this trial

Yi Lu, PhD

0086-023-63693099 kyc1892@qq.com

View on ClinicalTrials.gov More Primary Hypertension trials

Plain-language summary

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.
✓.24-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
✓. 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
✓. 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.

Exclusion criteria

✕. Carotid body anatomy is not eligible for treatment: ultrasound examination before treatment fail to find carotid body at carotid artery bifurcation.