To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension

NCT ID: NCT03261375

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2022-12-26

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.

Detailed Description

This is a prospective, multicenter, randomized sham-controlled trial. Patients with uncontrolled hypertension (office BP ≥150/90 and <180/110mmHg, and average SBP ≥135mmHg by 24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide), and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to RDN group and sham control group (renal artery angiography only). All continued with the 2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients and site investigators who evaluate the patients were blinded to treatment assignment. The primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post procedure and safety events.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Renal denervation (RDN) Group

Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)

Group Type: EXPERIMENTAL

Renal Artery Radiofrequency Ablation System (Generator and Catheter )

Intervention Type: DEVICE

A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator

Antihypertensive Agents

Intervention Type: DRUG

Calcium channel blocker, Diuretic

Control Group

Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only

Group Type: SHAM_COMPARATOR

Antihypertensive Agents

Intervention Type: DRUG

Calcium channel blocker, Diuretic

Sham Procedure

Intervention Type: DEVICE

Catheterization without renal denervation

Interventions

Renal Artery Radiofrequency Ablation System (Generator and Catheter )

A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator

Intervention Type: DEVICE

Antihypertensive Agents

Calcium channel blocker, Diuretic

Intervention Type: DRUG

Sham Procedure

Catheterization without renal denervation

Intervention Type: DEVICE

Other Intervention Names

Nifedipine and hydrochlorothiazide

Eligibility Criteria

Inclusion Criteria

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

2. 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;

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

4. Subject with confirmed diagnosis of essential hypertension;

5. Subject with or without accessary renal arteries;

6. 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.

Exclusion Criteria

1. Subject who is pregnant, nursing or planning to become pregnant during the study;

2. 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);

3. Subject who has unilateral kidney or kidney transplant;

4. Subject with a history of renal artery interventional therapy or renal denervation;

5. 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;

6. Subject with secondary hypertension;

7. Subject with pseudo-hypertension;

8. Subject with orthostatic hypotension;

9. Subject with eGFR <45mL/min/l.73m2;

10. Subject with average SBP is < 135mmHg on 24-hour ABPM;

11. Subject with a history of hospitalization for hypertensive emergency within past one year;

12. Subject with type I diabetes mellitus;

13. Subject with primary pulmonary hypertension;

14. Subject with a history of bleeding diathesis and hematological disorders;

15. Subject with a history of embolism within past 6 months;

16. Subject with a history of acute coronary syndrome within past 6 months;

17. Subject with a history of ventricular fibrillation, polymorphic ventricular tachycardia within past 6 months;

18. Subject with serum HIV-positive;

19. Subject who is allergic to contrast agents;

20. Subject with mental illness or any psychological problems that may interfere with the participating in the study;

21. Subject with a history of stroke or transient ischemic attack (TIA) within past 3 months;

22. Subject with malignant tumors or end-stage disease;

23. Subject with severe peripheral vascular disease or abdominal aortic aneurysm;

24. Subject with severe heart valve stenosis;

25. Subject with cardiac insufficiency (NYHA class III~IV);

26. Subject with hyperthyroidism or hypothyroidism;

27. Subject with severe electrolyte or liver function abnormalities;

28. Subject who requires mechanical ventilation other than nocturnal respiratory support for sleep apnea;

29. Subject with acute or severe systemic infection;

30. Subject with a history of pacemaker implantation;

31. Subject with a history of major surgery or trauma within 30 days prior to enrollment;

32. Subject who has planned surgery or cardiovascular intervention within the next 6 months;

33. Subject who is participating in other drug or medical device clinical trials;

34. Subject who has known drug or alcohol dependence, difficulty to understand the trial protocol, inability/unwillingness to follow the trial protocol;

35. Subject who is unsuitable for participating in this study in the opinion of investigators;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Golden Leaf MedTec Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yujie Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Anzhen Hospital

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Shijiazhuang People's Hospital

Shijiazhuang, Hebei, China

Nanyang Second People's Hospital

Nanyang, Henan, China

The Seventh People's Hospital of Zhengzhou

Zhengzhou, Henan, China

The 1st Affiliated Hospital Zhengzhou University

Zhengzhou, Henan, China

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Heze Municipal Hospital

Heze, Shandong, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

The First People's Hospital of Jining, Shandong Province

Jining, Shandong, China

Qingdao Central Hospital

Qingdao, Shangdong, China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Tangdu Hospital, Fourth Military Medical University

Xi’an, Shanxi, China

Xianyang Hospital of Yan 'an University

Yanan, Shanxi, China

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Huaxi Hospital

Chengdu, Sichuan, China

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Xinjiang Autonomous Region People's Hospital

Ürümqi, Xinjiang, China

Run Run Shaw Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Countries

China

Other Identifiers

MLWY-SXX201601

Identifier Type: -

Identifier Source: org_study_id