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Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Radiofrequency ablation catheter
Amlodipine, losartan potassium and hydrochlorothiazide
Sponsored by
Shanghai WiseGain Medical Devices Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Subject is ≥ 18 and < 80 years old at time of randomization.
  3. Subject agrees to have all study procedures performed, and willing to provide written informed consent to participate in this clinical study.

Exclusion Criteria:

  1. Subject has acute or serious systemic infection.
  2. Subject has a history of renal artery interventional therapy.
  3. 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.
  4. 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.
  5. Subject has aortic dissection aneurysm.
  6. Subject has primary pulmonary hypertension.
  7. Subject has an estimated glomerular filtration rate of less than 40 mL/min/1.73m² according to Modification of Diet in Renal Disease formula.
  8. Subject had a definite diagnose of coronary heart disease requiring beta blockers
  9. Subject has a Class III - IV of heart failure or left ventricular ejection fraction <45%.
  10. Subject had atrial fibrillation.
  11. Subject has a significant bleeding tendency or blood system disease(s).
  12. Subject has a malignancy or end-stage disease(s).
  13. Subject has secondary hypertension.
  14. Subject has type 1 diabetes mellitus.
  15. Subject has other conditions inappropriate for participation at the investigator's discretion.
  16. 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.

Sites / Locations

  • The Third Xiangya Hospital of Central South University
  • Zhongshan Hospital affiliated to Fu Dan University
  • Changhai Hospital affiliated to Second Military Medical University
  • Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University
  • Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University
  • Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University
  • Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University
  • Tongji Hospital affiliated to Tongji University
  • Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
  • Sir Run Run Shaw Hospital affiliated to Zhejiang University
  • The Second Hospital affiliated to Zhejiang University
  • Taizhou Hospital
  • The First Hospital affiliated to Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Renal Denervation plus Medications

Medications

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline

Secondary Outcome Measures

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
Change in daytime and nighttime ambulatory systolic blood pressure from baseline
Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline
Change in serum creatinine from baseline
Incidence of adverse event

Full Information

First Posted
September 7, 2016
Last Updated
September 9, 2016
Sponsor
Shanghai WiseGain Medical Devices Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02900729
Brief Title
Randomized Controlled Trial of Renal Denervation for Resistant Hypertension
Official Title
A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai WiseGain Medical Devices Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation plus Medications
Arm Type
Experimental
Arm Description
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
Arm Title
Medications
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Radiofrequency ablation catheter
Intervention Description
Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.
Intervention Type
Drug
Intervention Name(s)
Amlodipine, losartan potassium and hydrochlorothiazide
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline
Time Frame
3 months post-randomization
Secondary Outcome Measure Information:
Title
Incidence of achieving target blood pressure
Description
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
Time Frame
6 months post-randomization
Title
Change in daytime and nighttime ambulatory systolic blood pressure from baseline
Time Frame
3 months post-randomization
Title
Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline
Time Frame
3 months post-randomization
Title
Change in serum creatinine from baseline
Time Frame
6 months post-randomization
Title
Incidence of adverse event
Time Frame
Through study completion, up to 6 months
Other Pre-specified Outcome Measures:
Title
Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline
Time Frame
6 months post-randomization
Title
Change in office systolic/diastolic blood pressure from baseline
Time Frame
6 months post-randomization
Title
Change in patient-recorded home systolic/diastolic blood pressure from baseline
Time Frame
6 months post-randomization
Title
Incidences of achieving reductions of ≥ 5 mmHg, ≥ 10 mmHg, ≥15 mmHg, and ≥ 20 mmHg in blood pressure, including ambulatory, office and home blood pressure
Time Frame
6 months post-randomization
Title
Incidences of substantially adjusting antihypertensive medications
Description
A substantial adjustment of antihypertensive medications is defined as any changes in number of antihypertensive medications, or type of antihypertensive medications, or ≥ 50% dose change in any ongoing antihypertensive medications in the last two weeks.
Time Frame
6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Chen, Dr.
Phone
86-21-61400976
Email
helen6_2@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Dr.
Organizational Affiliation
Zhongshan Hospital affiliated to Fu Dan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihui Zhang, Dr.
Email
zhangzhihui0869@126.com
First Name & Middle Initial & Last Name & Degree
Xiaoyan Wang, Dr.
Facility Name
Zhongshan Hospital affiliated to Fu Dan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, Dr.
Email
ge.junbo@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Li Shen, Dr.
Email
shen.li@zs-hospital.sh.cn
Facility Name
Changhai Hospital affiliated to Second Military Medical University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xianxian Zhao, Dr.
Email
13601713431@163.com
First Name & Middle Initial & Last Name & Degree
Zhifu Guo, Dr.
Facility Name
Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongjun Liu, Dr.
Email
lzj72@126.com
First Name & Middle Initial & Last Name & Degree
Jia Shi, Dr.
Facility Name
Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiyi Fang, Dr.
Email
fwychest@163.com
First Name & Middle Initial & Last Name & Degree
Shaofeng Guan, Dr.
Email
gsf@qq.com
Facility Name
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changqian Wang, Dr.
Email
wcqian@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhaofang Yin, Dr.
Email
13072103901@163.com
Facility Name
Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingbo Li, Dr.
Email
jbli@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Yesheng Pan, Dr.
Email
panyesheng@163.com
Facility Name
Tongji Hospital affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuebo Liu, Dr.
Email
lxb70@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yang Liu, Dr.
Email
961165@sina.com
Facility Name
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
City
Shanghai
State/Province
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingmin Lu, Dr.
Email
lymkk@sohu.com
First Name & Middle Initial & Last Name & Degree
Shuxin Hou, Dr.
Email
1461396934@qq.com
Facility Name
Sir Run Run Shaw Hospital affiliated to Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guosheng Fu, Dr.
Email
fugs@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Chenyang Jiang, Dr.
Facility Name
The Second Hospital affiliated to Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianan Wang, Dr.
Email
wang_jian_an@tom.com
First Name & Middle Initial & Last Name & Degree
Jun Jiang, Dr.
Email
drjayj@Hotmail.com
Facility Name
Taizhou Hospital
City
Taizhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianjun Jiang, Dr.
Email
taizhoujiangjj@163.com
First Name & Middle Initial & Last Name & Degree
Yafei Mi, Dr.
Facility Name
The First Hospital affiliated to Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weijian Huang, Dr.
Email
weijianhuang69@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Zhouqing Huang, Dr.
Email
susiehzq@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24678939
Citation
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.
Results Reference
background
PubMed Identifier
28864691
Citation
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.
Results Reference
derived

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Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

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