HypertensionPhase 3NCT02900729

Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

A Phase 3 study testing Radiofrequency ablation catheter and Amlodipine, losartan potassium and hydrochlorothiazide in people with Hypertension, run by Shanghai WiseGain Medical Devices Co., Ltd. at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 79 years
Conditions the study is for: Hypertension
What is being tested?: Radiofrequency ablation catheter and Amlodipine, losartan potassium and hydrochlorothiazide
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 254 participants
Where: 13 sitesChina
Study dates: Oct 2016to Feb 2018
Phase: Phase 3
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 79 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject with primary hypertension has 24-hour ambulatory systolic blood pressure ≥ 135 mmHg and office systolic blood pressure ≥ 140 mmHg /office diastolic blood pressure ≥ 90 mmHg after a 4-week standardised triple therapy.
Subject is ≥ 18 and < 80 years old at time of randomization.
Subject agrees to have all study procedures performed, and willing to provide written informed consent to participate in this clinical study.

Who cannot join

Subject has acute or serious systemic infection.
Subject has a history of renal artery interventional therapy.
Subject lacks suitable renal artery anatomy for percutaneous renal sympathetic nerve radiofrequency ablation surgery, including not limited to a presence of serious aorta or renal-artery tortuosity or renal-artery stenosis.
Subject has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis.
Subject has aortic dissection aneurysm.
Subject has primary pulmonary hypertension.

Show all 16Show fewer

Subject has an estimated glomerular filtration rate of less than 40 mL/min/1.73m² according to Modification of Diet in Renal Disease formula.
Subject had a definite diagnose of coronary heart disease requiring beta blockers
Subject has a Class III - IV of heart failure or left ventricular ejection fraction <45%.
Subject had atrial fibrillation.
Subject has a significant bleeding tendency or blood system disease(s).
Subject has a malignancy or end-stage disease(s).
Subject has secondary hypertension.
Subject has type 1 diabetes mellitus.
Subject has other conditions inappropriate for participation at the investigator's discretion.
Subject has a medical ethics of concern at the investigator's discretion, such as a presence of 24-hour Ambulatory Blood Pressure Monitoring average systolic blood pressure ≥ 170 mmHg after a 4-week standardised triple therapy.

Trial locations and contacts

13 sites in 1 country.

Helen Chen, Dr. contact

86-21-61400976

helen6_2@163.com

City, postcode or hospital

13 sites in 1 country

China13 sites

The Third Xiangya Hospital of Central South University
Changsha, Hunan
Zhihui Zhang, Dr., zhangzhihui0869@126.com
Xiaoyan Wang, Dr.
Sir Run Run Shaw Hospital affiliated to Zhejiang University
Hangzhou, Zhejiang
Guosheng Fu, Dr., fugs@medmail.com.cn
Chenyang Jiang, Dr.
The Second Hospital affiliated to Zhejiang University
Hangzhou, Zhejiang
Jianan Wang, Dr., wang_jian_an@tom.com
Jun Jiang, Dr., drjayj@Hotmail.com
Zhongshan Hospital affiliated to Fu Dan University
Shanghai, Shanghai Municipality, 200032
Junbo Ge, Dr., ge.junbo@zs-hospital.sh.cn
Li Shen, Dr., shen.li@zs-hospital.sh.cn
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality
Xianxian Zhao, Dr., 13601713431@163.com
Zhifu Guo, Dr.
Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University
Shanghai, Shanghai Municipality
Zongjun Liu, Dr., lzj72@126.com
Jia Shi, Dr.
Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Weiyi Fang, Dr., fwychest@163.com
Shaofeng Guan, Dr., gsf@qq.com
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Changqian Wang, Dr., wcqian@hotmail.com
Zhaofang Yin, Dr., 13072103901@163.com
Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Jingbo Li, Dr., jbli@medmail.com.cn
Yesheng Pan, Dr., panyesheng@163.com
Tongji Hospital affiliated to Tongji University
Shanghai, Shanghai Municipality
Xuebo Liu, Dr., lxb70@hotmail.com
Yang Liu, Dr., 961165@sina.com
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
Shanghai, Shanghai Municipality
Yingmin Lu, Dr., lymkk@sohu.com
Shuxin Hou, Dr., 1461396934@qq.com
Taizhou Hospital
Taizhou, Zhejiang
Jianjun Jiang, Dr., taizhoujiangjj@163.com
Yafei Mi, Dr.
The First Hospital affiliated to Wenzhou Medical College
Wenzhou, Zhejiang
Weijian Huang, Dr., weijianhuang69@yahoo.com.cn
Zhouqing Huang, Dr., susiehzq@126.com

Other trials in China

About this study

Official title: A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension

Hypertension represents a significant global public health problem, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic disease, there is a huge challenge to maintain a good adherence and longtime persistence of drug use so as to adequately control it. Even so, a significant proportion of patients will develop resistant hypertension. In recent years, renal denervation has been argued as an effective means to address blood pressure problem in several non-Chinese clinical trials. The technique is to deliver low level radiofrequency energy through the renal artery wall to target the sympathetic nervous system and then modulate blood pressure.

Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve blood pressure status among patients with resistant hypertension failing polypharmacy. The purpose of this randomized control trial is to obtain an assessment of the efficacy and safety of WiseGo renal denervation technique in the presence of three standard antihypertensive medications in Chinese patients.

Conditions: Hypertension
Being tested: Radiofrequency ablation catheter, Amlodipine, losartan potassium and hydrochlorothiazide
Medical subject headings: Hypertension

What participants receive

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

Radiofrequency ablation catheterDevice
Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.
Amlodipine, losartan potassium and hydrochlorothiazideDrug
Standardised triple anti-hypertensive medications of amlodipine 5 mg per day, losartan potassium 50 mg and hydrochlorothiazide 12.5 mg per day in the first 90 days after randomization. Subjects will be allowed to adjust baseline antihypertensive medications where clinically necessary in the second 90 days after randomization.

Study groups in NCT02900729
Study group	Role	What they receive
Renal Denervation plus Medications	Experimental	Renal denervation procedure after randomization plus maintenance of baseline standardised triple anti-hypertensive medications for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days Receives: Device: Radiofrequency ablation catheter; Drug: Amlodipine, losartan potassium and hydrochlorothiazide
Medications	Active comparator	Maintenance of baseline standardised triple antihypertensive medications after randomization for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days, after which, subjects will be allowed to cross over to perform renal denervation if they still meet the inclusion criteria for the study. Receives: Drug: Amlodipine, losartan potassium and hydrochlorothiazide

What is being measured

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

Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline
Measured: 3 months post-randomization

Secondary outcomes (5)

Incidence of achieving target blood pressure
Target blood pressure is defined as daytime ambulatory blood pressure <135/85mmHg, nighttime ambulatory blood pressure <120/70mmHg or average 24-hour ambulatory blood pressure <130/80mmHg, respectively
Measured: 6 months post-randomization
Change in daytime and nighttime ambulatory systolic blood pressure from baseline
Measured: 3 months post-randomization
Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline
Measured: 3 months post-randomization
Change in serum creatinine from baseline
Measured: 6 months post-randomization
Incidence of adverse event
Measured: Through study completion, up to 6 months

Timeline

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

Oct 2016Feb 2018

First posted14 Sep 2016 (estimated)
Study startOct 2016
Primary completionAug 2017 (estimated)
Study completionFeb 2018 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 254 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02900729
Sponsor's protocol ID: WiseGo-CT-1601
Status last verified: Sep 2016
First submitted: 7 Sep 2016
Last updated: 14 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
PubMed 24678939
Liu Z, Shen L, Huang W, Zhao X, Fang W, Wang C, Yin Z, Wang J, Fu G, Liu X, Jiang J, Zhang Z, Li J, Lu Y, Ge J. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial. BMJ Open. 2017 Sep 1;7(9):e015672. doi: 10.1136/bmjopen-2016-015672.
PubMed 28864691

Want to know more?

Helen Chen, Dr.

86-21-61400976

helen6_2@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension
ClinicalTrials.gov ID: NCT02900729
Acronym / sponsor ID: WiseGo-CT-1601
Conditions: Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 254 participants (estimated)
Lead sponsor: Shanghai WiseGain Medical Devices Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2016
Primary completion: Aug 2017 (estimated)
Study completion: Feb 2018 (estimated)
First posted: 14 Sep 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Renal Denervation plus Medications	Experimental	Device: Radiofrequency ablation catheter, Drug: Amlodipine, losartan potassium and hydrochlorothiazideRenal denervation procedure after randomization plus maintenance of baseline standardised triple anti-hypertensive medications for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days
Medications	Active comparator	Drug: Amlodipine, losartan potassium and hydrochlorothiazideMaintenance of baseline standardised triple antihypertensive medications after randomization for 90 days and then medically necessary adjustment of antihypertensive medications for another 90 days, after which, subjects will be allowed to cross over to perform renal denervation if they still meet the inclusion criteria for the study.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subject with primary hypertension has 24-hour ambulatory systolic blood pressure ≥ 135 mmHg and office systolic blood pressure ≥ 140 mmHg /office diastolic blood pressure ≥ 90 mmHg after a 4-week standardised triple therapy.
Subject is ≥ 18 and < 80 years old at time of randomization.
Subject agrees to have all study procedures performed, and willing to provide written informed consent to participate in this clinical study.

Key exclusion criteria (16 listed)

Subject has acute or serious systemic infection.
Subject has a history of renal artery interventional therapy.
Subject lacks suitable renal artery anatomy for percutaneous renal sympathetic nerve radiofrequency ablation surgery, including not limited to a presence of serious aorta or renal-artery tortuosity or renal-artery stenosis.
Subject has experienced a myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within three months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis.
Subject has aortic dissection aneurysm.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency ablation catheterSubjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.	Device	Renal Denervation plus Medications
Amlodipine, losartan potassium and hydrochlorothiazideStandardised triple anti-hypertensive medications of amlodipine 5 mg per day, losartan potassium 50 mg and hydrochlorothiazide 12.5 mg per day in the first 90 days after randomization. Subjects will be allowed to adjust baseline antihypertensive medications where clinically necessary in the second 90 days after randomization.	Drug	Medications, Renal Denervation plus Medications

Primary outcome

Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline
Time frame: 3 months post-randomization

5 secondary outcomes

Incidence of achieving target blood pressure
Time frame: 6 months post-randomization
Change in daytime and nighttime ambulatory systolic blood pressure from baseline
Time frame: 3 months post-randomization
Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline
Time frame: 3 months post-randomization
Change in serum creatinine from baseline
Time frame: 6 months post-randomization
Incidence of adverse event
Time frame: Through study completion, up to 6 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Background: PubMed 24678939Bhatt DL, Kandzari DE, O'Neill WW, D'Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, Cohen SA, Oparil S, Rocha-Singh K, Townsend RR, Bakris GL; SYMPLICITY HTN-3 Investigators. A controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014 Apr 10;370(15):1393-401. doi: 10.1056/NEJMoa1402670. Epub 2014 Mar 29.
Derived from this study: PubMed 28864691Liu Z, Shen L, Huang W, Zhao X, Fang W, Wang C, Yin Z, Wang J, Fu G, Liu X, Jiang J, Zhang Z, Li J, Lu Y, Ge J. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial. BMJ Open. 2017 Sep 1;7(9):e015672. doi: 10.1136/bmjopen-2016-015672.
Individual participant dataSharing planned: No

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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Chen, Dr. contact

86-21-61400976

helen6_2@163.com

Junbo Ge, Dr. principal investigator

Zhongshan Hospital affiliated to Fu Dan University

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Helen Chen, Dr. (86-21-61400976, helen6_2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline (time frame: 3 months post-randomization). 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 NCT02900729, which also lists 2 linked publications.

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 14 Sep 2016.