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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261375
• Other study ID #: MLWY-SXX201601
• Status: Completed
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: December 26, 2022

Study information

• Verified date: January 2023
• Source: Shanghai Golden Leaf MedTec Co. Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: December 26, 2022
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Device:
• 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

Drug:
• Antihypertensive Agents
Calcium channel blocker, Diuretic

Device:
• Sham Procedure
Catheterization without renal denervation

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Huaxi Hospital	Chengdu	Sichuan
China	Run Run Shaw Hospital, Zhejiang University School of Medicine	Hanzhou	Zhejiang
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	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu
China	Nanyang Second People's Hospital	Nanyang	Henan
China	Qingdao Central Hospital	Qingdao	Shangdong
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shanghai Tongji Hospital	Shanghai	Shanghai
China	Shijiazhuang People's Hospital	Shijiazhuang	Hebei
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	The Second Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Xinjiang Autonomous Region People's Hospital	Ürümqi	Xinjiang
China	Tangdu Hospital, Fourth Military Medical University	Xi'an	Shanxi
China	Xianyang Hospital of Yan 'an University	Yanan	Shanxi
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Yuncheng Central Hospital	Yuncheng	Shanxi
China	The 1st Affiliated Hospital Zhengzhou University	Zhengzhou	Henan
China	The Seventh People's Hospital of Zhengzhou	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Golden Leaf MedTec Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Office DBP change from baseline at 6 months post procedure	Change in office blood diastolic pressure (DBP) at 6 months post procedure	From baseline to 6 months
Secondary	Changes in 24-hour ambulatory BP at 6 months post procedure	Changes in 24-hour ambulatory SBP and DBP from baseline at 6 months post procedure measured by 24-hour ABPM	From baseline to 6 months
Secondary	Incidence of achieving target office SBP (90mmHg=SBP<140mmHg) at 6 months post procedure	Patient proportion of achieving target office SBP (90mmHg=SBP<140mmHg) at 6 months post index procedure	From baseline to 6 months
Secondary	Proportion of office SBP decreased by = 5mmHg at 6 months post index procedure	Proportion of office SBP decreased by = 5mmHg at 6 months post index procedure	From baseline to 6 months
Secondary	The rate of major adverse events (MAE) through 6 months post index procedure	The rate of major adverse events (MAE) through 6 months post index procedure	From index procedure to 6 months post procedure