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HypertensionNCT03261375

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

A study testing Renal Artery Radiofrequency Ablation System (Generator and Catheter ) and Antihypertensive Agents in people with Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 25 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hypertension
What is being tested?
Renal Artery Radiofrequency Ablation System (Generator and Catheter ) and Antihypertensive Agents
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
205 participants
Where
25 sitesChina
Study dates
19 Jan 2021to 26 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Subject with a history of acute coronary syndrome within past 6 months;
  • Subject with a history of ventricular fibrillation, polymorphic ventricular tachycardia within past 6 months;
  • Subject with serum HIV-positive;
  • Subject who is allergic to contrast agents;
  • Subject with mental illness or any psychological problems that may interfere with the participating in the study;
  • Subject with a history of stroke or transient ischemic attack (TIA) within past 3 months;
  • Subject with malignant tumors or end-stage disease;
  • Subject with severe peripheral vascular disease or abdominal aortic aneurysm;
  • Subject with severe heart valve stenosis;
  • Subject with cardiac insufficiency (NYHA class III~IV);
  • Subject with hyperthyroidism or hypothyroidism;
  • Subject with severe electrolyte or liver function abnormalities;
  • Subject who requires mechanical ventilation other than nocturnal respiratory support for sleep apnea;
  • Subject with acute or severe systemic infection;
  • Subject with a history of pacemaker implantation;
  • Subject with a history of major surgery or trauma within 30 days prior to enrollment;
  • Subject who has planned surgery or cardiovascular intervention within the next 6 months;
  • Subject who is participating in other drug or medical device clinical trials;
  • Subject who has known drug or alcohol dependence, difficulty to understand the trial protocol, inability/unwillingness to follow the trial protocol;
  • Subject who is unsuitable for participating in this study in the opinion of investigators;

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Beijing Anzhen Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Huaxi Hospital

    Chengdu, Sichuan, 610044

  • Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310020

  • Heze Municipal Hospital

    Heze, Shandong, 274099

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First People's Hospital of Jining, Shandong Province

    Jining, Shandong, 272002

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, 210009

  • Nanyang Second People's Hospital

    Nanyang, Henan, 473009

  • Qingdao Central Hospital

    Qingdao, Shangdong, 266042

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality, 200065

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200940

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, 050030

  • The Second Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Tianjin Chest Hospital

    Tianjin, Tianjin Municipality, 300022

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830011

  • Xinjiang Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830011

  • Tangdu Hospital, Fourth Military Medical University

    Xi’an, Shanxi, 100005

  • Xianyang Hospital of Yan 'an University

    Yanan, Shanxi, 716099

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

  • Yuncheng Central Hospital

    Yuncheng, Shanxi, 044099

  • The Seventh People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450016

  • The 1st Affiliated Hospital Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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

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.

Read the 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
Being tested
Renal Artery Radiofrequency Ablation System (Generator and Catheter ), Antihypertensive Agents, Sham Procedure
Keywords
Hypertension, Renal Denervation
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal Artery Radiofrequency Ablation System (Generator and Catheter )Device

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

  • Antihypertensive AgentsDrug

    Also called Nifedipine and hydrochlorothiazide

    Calcium channel blocker, Diuretic

  • Sham ProcedureDevice

    Catheterization without renal denervation

Study groups in NCT03261375
Study groupRoleWhat they receive
Renal denervation (RDN) GroupExperimentalReceive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal denervation treatments (RDN)
Receives: Device: Renal Artery Radiofrequency Ablation System (Generator and Catheter ); Drug: Antihypertensive Agents
Control GroupSham comparatorReceive standardized 2 drugs (Nifedipine and hydrochlorothiazide) treatment and renal artery angiography only
Receives: Drug: Antihypertensive Agents; Device: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Office SBP change from baseline at 6 months post procedure

    Change in office blood systolic pressure (SBP) at 6 months post procedure

    Measured: From baseline to 6 months

Secondary outcomes (5)

  1. Office DBP change from baseline at 6 months post procedure

    Change in office blood diastolic pressure (DBP) at 6 months post procedure

    Measured: From baseline to 6 months

  2. 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

    Measured: From baseline to 6 months

  3. 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

    Measured: From baseline to 6 months

  4. 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

    Measured: From baseline to 6 months

  5. 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

    Measured: From index procedure to 6 months post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start19 Jan 2021
  3. Primary completion26 Dec 2022
  4. Study completion26 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
205 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261375
Sponsor's protocol ID
MLWY-SXX201601
Status last verified
Jan 2023
First submitted
21 Aug 2017
Last updated
4 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Renal Artery Radiofrequency Ablation System (Generator and Catheter ) and Antihypertensive Agents in people with Hypertension, run by Shanghai Golden Leaf MedTec Co. Ltd at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Office SBP change from baseline at 6 months post procedure (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03261375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.

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