Clinical trial NCT03261375: To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Renal Denervation
Lead sponsor: Shanghai Golden Leaf MedTec Co. Ltd
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Office SBP change from baseline at 6 months post procedure
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Office DBP change from baseline at 6 months post procedure
timeFrame: From baseline to 6 months
measure: Changes in 24-hour ambulatory BP at 6 months post procedure
timeFrame: From baseline to 6 months
measure: Incidence of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post procedure
timeFrame: From baseline to 6 months
measure: Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
timeFrame: From baseline to 6 months
measure: The rate of major adverse events (MAE) through 6 months post index procedure
timeFrame: From index procedure to 6 months post procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Shijiazhuang
country: China
facility: Shijiazhuang People's Hospital
state: Hebei
city: Nanyang
country: China
facility: Nanyang Second People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The Seventh People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The 1st Affiliated Hospital Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Heze
country: China
facility: Heze Municipal Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: The First People's Hospital of Jining, Shandong Province
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shangdong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The Second Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Xi'an
country: China
facility: Tangdu Hospital, Fourth Military Medical University
state: Shanxi
city: Yanan
country: China
facility: Xianyang Hospital of Yan 'an University
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: Huaxi Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Ürümqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ürümqi
country: China
facility: Xinjiang Autonomous Region People's Hospital
state: Xinjiang
city: Hanzhou
country: China
facility: Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Beijing Anzhen Hospital
name: Yujie Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: