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

January 2, 2023 updated by: Shanghai Golden Leaf MedTec Co. Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital, Capital Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Lanzhou University Second Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050030
        • Shijiazhuang People's Hospital
    • Henan
      • Nanyang, Henan, China, 473009
        • Nanyang Second People's Hospital
      • Zhengzhou, Henan, China, 450016
        • The Seventh People's Hospital of Zhengzhou
      • Zhengzhou, Henan, China, 450052
        • The 1st Affiliated Hospital Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Zhongda Hospital, Southeast University
    • Ningxia
      • Yinchuan, Ningxia, China, 750003
        • General Hospital of Ningxia Medical University
    • Shandong
      • Heze, Shandong, China, 274099
        • Heze Municipal Hospital
      • Jinan, Shandong, China, 250012
        • Qilu Hospital of Shandong University
      • Jining, Shandong, China, 272002
        • The First People's Hospital of Jining, Shandong Province
    • Shangdong
      • Qingdao, Shangdong, China, 266042
        • Qingdao Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200065
        • Shanghai Tongji Hospital
      • Shanghai, Shanghai, China, 200940
        • Shanghai First People's Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • The Second Affiliated Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, China, 030032
        • Shanxi Bethune Hospital
      • Xi'an, Shanxi, China, 100005
        • Tangdu Hospital, Fourth Military Medical University
      • Yanan, Shanxi, China, 716099
        • Xianyang Hospital of Yan 'an University
      • Yuncheng, Shanxi, China, 044099
        • Yuncheng Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Huaxi Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 300022
        • Tianjin Chest Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830011
        • The First Affiliated Hospital of Xinjiang Medical University
      • Ürümqi, Xinjiang, China, 830011
        • Xinjiang Autonomous Region People's Hospital
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310020
        • Run Run Shaw Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Renal denervation (RDN) Group
Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)
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
Other Names:
  • Nifedipine and hydrochlorothiazide
Sham Comparator: Control Group
Receive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only
Drug: Antihypertensive Agents
Calcium channel blocker, Diuretic
Other Names:
  • Nifedipine and hydrochlorothiazide
Device: Sham Procedure
Catheterization without renal denervation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Office SBP change from baseline at 6 months post procedure
Time Frame: From baseline to 6 months
Change in office blood systolic pressure (SBP) at 6 months post procedure
From baseline to 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Office DBP change from baseline at 6 months post procedure
Time Frame: From baseline to 6 months
Change in office blood diastolic pressure (DBP) at 6 months post procedure
From baseline to 6 months
Changes in 24-hour ambulatory BP at 6 months post procedure
Time Frame: From baseline to 6 months
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
Incidence of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post procedure
Time Frame: From baseline to 6 months
Patient proportion of achieving target office SBP (90mmHg≤SBP<140mmHg) at 6 months post index procedure
From baseline to 6 months
Proportion of office SBP decreased by ≥ 5mmHg at 6 months post index procedure
Time Frame: 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
Time Frame: From index procedure to 6 months post procedure
The rate of major adverse events (MAE) through 6 months post index procedure
From index procedure to 6 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Golden Leaf MedTec Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yujie Zhou, MD, Beijing Anzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MLWY-SXX201601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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