Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, China
Location status: Recruiting
NCT Number: NCT06877221
Prospective, multicenter, randomized, controlled, blinded, and superiority - designed; The target population undergoes a screening treatment with prescribed medications for at least 4 weeks. Eligible subjects are randomly assigned to the experimental group and the control group at a ratio of 2:1. The experimental group is treated with the ultrasound nerve ablation catheter and the ultrasound nerve ablation device of Shenzhen Maiwei Medical Technology Co., Ltd., while the control group only undergoes renal arteriography (regarded as a sham operation). Within 6 months after the operation, both groups continue to receive antihypertensive drug treatment with the dosage and types specified during the screening period. The subjects are kept blinded during the study. The relative change values of the average 24 - hour ambulatory systolic blood pressure from the baseline at 6 months after the operation are compared between the two groups.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Guangzhou, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treat with an ultrasound nerve ablation catheter and an ultrasound nerve ablation device
Time frame: Six months after surgery
The average change value of 24 - hour ambulatory systolic blood pressure (ASBP) relative to the baseline at 6 months after surgery
Time frame: 3 months and 6 months after surgery
The changes in clinic systolic and diastolic blood pressures relative to the baseline at 3 months and 6 months after surgery
Time frame: 3 months and 6 months after surgery
The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery The attainment rate of clinic systolic blood pressure (90 mmHg ≤ SBP < 140 mmHg) at 3 months and 6 months after surgery
Time frame: 3 months and 6 months after surgery
The average change values of 24 - hour ambulatory diastolic blood pressure relative to the baseline at 3 months and 6 months after surgery
Time frame: Three months after surgery
The average change value of 24 - hour ambulatory systolic blood pressure relative to the baseline at 3 months after surgery
Time frame: 3 months and 6 months after surgery
The proportion of patients with a reduction in clinic systolic blood pressure of ≥ 5 mmHg, 10 mmHg, 15 mmHg, and 20 mmHg at 3 months and 6 months after surgery
Time frame: Six months after surgery
Changes in the drug composite index of the types and dosages of antihypertensive drugs 6 months after surgery
Contact information is provided by the study sponsor or research team.
Shenzhen Pulsecare Medical Technology Co., Ltd.
Industry
A Prospective, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Effectiveness and Safety of an Ultrasound Renal Denervation Catheter in Combination With an Ultrasound Renal Denervation Device for the Treatment of Refractory Hypertension or Drug - Intolerant Hypertension
Acronym: ModulationHTN2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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