To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension
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
1 other identifier
interventional
205
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hypertension
Started Jan 2021
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 25, 2017
CompletedStudy Start
First participant enrolled
January 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2022
CompletedJanuary 4, 2023
January 1, 2023
1.9 years
August 21, 2017
January 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Office SBP change from baseline at 6 months post procedure
Change in office blood systolic pressure (SBP) at 6 months post procedure
From baseline to 6 months
Secondary Outcomes (5)
Office DBP change from baseline at 6 months post procedure
From baseline to 6 months
Changes in 24-hour ambulatory BP at 6 months post procedure
From baseline to 6 months
Incidence of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post procedure
From baseline to 6 months
Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
From baseline to 6 months
The rate of major adverse events (MAE) through 6 months post index procedure
From index procedure to 6 months post procedure
Study Arms (2)
Renal denervation (RDN) Group
EXPERIMENTALReceive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)
Control Group
SHAM COMPARATORReceive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only
Interventions
A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator
Calcium channel blocker, Diuretic
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subject who is pregnant, nursing or planning to become pregnant during the study;
- Subject with the shape and structure of unilateral or bilateral renal artery that are not suitable for ablation procedure (renal artery stenosis more than 50%, renal aneurysm, renal artery abnormality, renal artery diameter \<4mm or treatable segment length \<20mm);
- Subject who has unilateral kidney or kidney transplant;
- Subject with a history of renal artery interventional therapy or renal denervation;
- Subject with any conditions that may affect the accuracy of blood pressure measurement: such as the diameter of the upper arm is too large relative to the cuff, arrhythmia;
- Subject with secondary hypertension;
- Subject with pseudo-hypertension;
- Subject with orthostatic hypotension;
- Subject with eGFR \<45mL/min/l.73m2;
- Subject with average SBP is \< 135mmHg on 24-hour ABPM;
- Subject with a history of hospitalization for hypertensive emergency within past one year;
- Subject with type I diabetes mellitus;
- Subject with primary pulmonary hypertension;
- Subject with a history of bleeding diathesis and hematological disorders;
- Subject with a history of embolism within past 6 months;
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, 050030, China
Nanyang Second People's Hospital
Nanyang, Henan, 473009, China
The Seventh People's Hospital of Zhengzhou
Zhengzhou, Henan, 450016, China
The 1st Affiliated Hospital Zhengzhou University
Zhengzhou, Henan, 450052, China
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750003, China
Heze Municipal Hospital
Heze, Shandong, 274099, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The First People's Hospital of Jining, Shandong Province
Jining, Shandong, 272002, China
Qingdao Central Hospital
Qingdao, Shangdong, 266042, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, 200065, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200940, China
The Second Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Tangdu Hospital, Fourth Military Medical University
Xi’an, Shanxi, 100005, China
Xianyang Hospital of Yan 'an University
Yanan, Shanxi, 716099, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
Huaxi Hospital
Chengdu, Sichuan, 610044, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300022, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011, China
Xinjiang Autonomous Region People's Hospital
Ürümqi, Xinjiang, 830011, China
Run Run Shaw Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yujie Zhou, MD
Beijing Anzhen Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Both patients and site investigators who evaluate the patients were blinded to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2017
First Posted
August 25, 2017
Study Start
January 19, 2021
Primary Completion
December 26, 2022
Study Completion
December 26, 2022
Last Updated
January 4, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share