Prospective Multicenter Randomized Parallel Controlled Clinical Trial to Evaluate the Safety and Effectiveness of a Radiofrequency Renal Denervation System for the Treatment of Essential Hypertension

Status: Completed
Location: See all (25) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in treating patients with uncontrolled essential hypertension.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Subject with age of 18 to 65 years old (include 65), male or female;

• Subject with essential hypertension who has an office BP of ≥150/90mmHg and \<180/110 mmHg (both SBP and DBP meet the criteria), and an average SBP of ≥ 135mmHg measured by 24-hour ABPM, after taking ≥ 2 antihypertensive medications for ≥ 4 weeks;

• Subject with the resting heart rate ≥70bpm, if not taking beta-blockers (this criterion does not apply to those taking beta-blockers);

• Subject with confirmed diagnosis of essential hypertension;

• Subject with or without accessary renal arteries;

• Subject who has signed the informed consent form, agrees to participate in this clinical trial, and is willing to comply with the required follow-ups per the trial protocol.

Locations
Other Locations
China
Beijing Anzhen Hospital, Capital Medical University
Beijing
Chinese PLA General Hospital
Beijing
Huaxi Hospital
Chengdu
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hanzhou
Heze Municipal Hospital
Heze
Qilu Hospital of Shandong University
Jinan
The First People's Hospital of Jining, Shandong Province
Jining
Lanzhou University Second Hospital
Lanzhou
Zhongda Hospital, Southeast University
Nanjing
Nanyang Second People's Hospital
Nanyang
Qingdao Central Hospital
Qingdao
Shanghai First People's Hospital
Shanghai
Shanghai Tongji Hospital
Shanghai
Shijiazhuang People's Hospital
Shijiazhuang
Shanxi Bethune Hospital
Taiyuan
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan
Tianjin Chest Hospital
Tianjin
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi
Xinjiang Autonomous Region People's Hospital
Ürümqi
Tangdu Hospital, Fourth Military Medical University
Xi’an
Xianyang Hospital of Yan 'an University
Yanan
General Hospital of Ningxia Medical University
Yinchuan
Yuncheng Central Hospital
Yuncheng
The 1st Affiliated Hospital Zhengzhou University
Zhengzhou
The Seventh People's Hospital of Zhengzhou
Zhengzhou
Time Frame
Start Date: 2021-01-19
Completion Date: 2022-12-26
Participants
Target number of participants: 205
Treatments
Experimental: Renal denervation (RDN) Group
Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)
Sham_comparator: Control Group
Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only
Related Therapeutic Areas
Sponsors
Leads: Shanghai Golden Leaf MedTec Co. Ltd

This content was sourced from clinicaltrials.gov

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