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Trial record 58 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900729
Recruitment Status : Unknown
Verified September 2016 by Shanghai WiseGain Medical Devices Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai WiseGain Medical Devices Co., Ltd.

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.


Condition or disease Intervention/treatment Phase
Hypertension Device: Radiofrequency ablation catheter Drug: Amlodipine, losartan potassium and hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Trial of Efficacy and Safety of Renal Denervation for Resistant Hypertension
Study Start Date : October 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium

Arm Intervention/treatment
Experimental: Renal Denervation plus Medications
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
Device: Radiofrequency ablation catheter
Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.

Drug: Amlodipine, losartan potassium and hydrochlorothiazide
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.

Active Comparator: Medications
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.
Drug: Amlodipine, losartan potassium and hydrochlorothiazide
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 Measures :
  1. Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline [ Time Frame: 3 months post-randomization ]

Secondary Outcome Measures :
  1. Incidence of achieving target blood pressure [ Time Frame: 6 months post-randomization ]
    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

  2. Change in daytime and nighttime ambulatory systolic blood pressure from baseline [ Time Frame: 3 months post-randomization ]
  3. Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline [ Time Frame: 3 months post-randomization ]
  4. Change in serum creatinine from baseline [ Time Frame: 6 months post-randomization ]
  5. Incidence of adverse event [ Time Frame: Through study completion, up to 6 months ]

Other Outcome Measures:
  1. Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline [ Time Frame: 6 months post-randomization ]
  2. Change in office systolic/diastolic blood pressure from baseline [ Time Frame: 6 months post-randomization ]
  3. Change in patient-recorded home systolic/diastolic blood pressure from baseline [ Time Frame: 6 months post-randomization ]
  4. 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 ]
  5. Incidences of substantially adjusting antihypertensive medications [ Time Frame: 6 months post-randomization ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900729


Contacts
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Contact: Helen Chen, Dr. 86-21-61400976 helen6_2@163.com

Locations
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China, Hunan
The Third Xiangya Hospital of Central South University Not yet recruiting
Changsha, Hunan, China
Contact: Zhihui Zhang, Dr.       zhangzhihui0869@126.com   
Contact: Xiaoyan Wang, Dr.         
China, Shanghai
Zhongshan Hospital affiliated to Fu Dan University Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Junbo Ge, Dr.       ge.junbo@zs-hospital.sh.cn   
Contact: Li Shen, Dr.       shen.li@zs-hospital.sh.cn   
Changhai Hospital affiliated to Second Military Medical University Not yet recruiting
Shanghai, Shanghai, China
Contact: Xianxian Zhao, Dr.       13601713431@163.com   
Contact: Zhifu Guo, Dr.         
Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University Not yet recruiting
Shanghai, Shanghai, China
Contact: Zongjun Liu, Dr.       lzj72@126.com   
Contact: Jia Shi, Dr.         
Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University Not yet recruiting
Shanghai, Shanghai, China
Contact: Weiyi Fang, Dr.       fwychest@163.com   
Contact: Shaofeng Guan, Dr.       gsf@qq.com   
Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University Not yet recruiting
Shanghai, Shanghai, China
Contact: Changqian Wang, Dr.       wcqian@hotmail.com   
Contact: Zhaofang Yin, Dr.       13072103901@163.com   
Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University Not yet recruiting
Shanghai, Shanghai, China
Contact: Jingbo Li, Dr.       jbli@medmail.com.cn   
Contact: Yesheng Pan, Dr.       panyesheng@163.com   
Tongji Hospital affiliated to Tongji University Not yet recruiting
Shanghai, Shanghai, China
Contact: Xuebo Liu, Dr.       lxb70@hotmail.com   
Contact: Yang Liu, Dr.       961165@sina.com   
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch Not yet recruiting
Shanghai, Shanghai, China
Contact: Yingmin Lu, Dr.       lymkk@sohu.com   
Contact: Shuxin Hou, Dr.       1461396934@qq.com   
China, Zhejiang
Sir Run Run Shaw Hospital affiliated to Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Guosheng Fu, Dr.       fugs@medmail.com.cn   
Contact: Chenyang Jiang, Dr.         
The Second Hospital affiliated to Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Jianan Wang, Dr.       wang_jian_an@tom.com   
Contact: Jun Jiang, Dr.       drjayj@Hotmail.com   
Taizhou Hospital Not yet recruiting
Taizhou, Zhejiang, China
Contact: Jianjun Jiang, Dr.       taizhoujiangjj@163.com   
Contact: Yafei Mi, Dr.         
The First Hospital affiliated to Wenzhou Medical College Not yet recruiting
Wenzhou, Zhejiang, China
Contact: Weijian Huang, Dr.       weijianhuang69@yahoo.com.cn   
Contact: Zhouqing Huang, Dr.       susiehzq@126.com   
Sponsors and Collaborators
Shanghai WiseGain Medical Devices Co., Ltd.
Investigators
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Principal Investigator: Junbo Ge, Dr. Zhongshan Hospital affiliated to Fu Dan University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shanghai WiseGain Medical Devices Co., Ltd.
ClinicalTrials.gov Identifier: NCT02900729     History of Changes
Other Study ID Numbers: WiseGo-CT-1601
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Losartan
Hydrochlorothiazide
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors