Clinical trial NCT02900729: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: Shanghai WiseGain Medical Devices Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-14
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline
timeFrame: 3 months post-randomization
Secondary outcomes:
measure: Incidence of achieving target blood pressure
timeFrame: 6 months post-randomization
measure: Change in daytime and nighttime ambulatory systolic blood pressure from baseline
timeFrame: 3 months post-randomization
measure: Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline
timeFrame: 3 months post-randomization
measure: Change in serum creatinine from baseline
timeFrame: 6 months post-randomization
measure: Incidence of adverse event
timeFrame: Through study completion, up to 6 months
Other outcomes:
measure: Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline
timeFrame: 6 months post-randomization
measure: Change in office systolic/diastolic blood pressure from baseline
timeFrame: 6 months post-randomization
measure: Change in patient-recorded home systolic/diastolic blood pressure from baseline
timeFrame: 6 months post-randomization
measure: Incidences of achieving reductions of ≥ 5 mmHg, ≥ 10 mmHg, ≥15 mmHg, and ≥ 20 mmHg in blood pressure, including ambulatory, office and home blood pressure
timeFrame: 6 months post-randomization
measure: Incidences of substantially adjusting antihypertensive medications
timeFrame: 6 months post-randomization
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fu Dan University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital affiliated to Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Putuo Hospital affiliated to Shanghai Traditional Chinese Medicine University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Chest Hospital affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital affiliated to Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital affiliated to Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine Chongming Branch
state: Shanghai
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated to Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Hospital affiliated to Zhejiang University
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Hospital affiliated to Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Zhongshan Hospital affiliated to Fu Dan University
name: Junbo Ge, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.