Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02900729
• Other study ID #: WiseGo-CT-1601
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 7, 2016
• Last updated: September 9, 2016
• Start date: October 2016
• Est. completion date: February 2018

Study information

• Verified date: September 2016
• Source: Shanghai WiseGain Medical Devices Co., Ltd.
• Contact: Helen Chen, Dr.
• Phone: 86-21-61400976
• Email: helen6_2[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: February 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai WiseGain Medical Devices Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline		6 months post-randomization	No
Other	Change in office systolic/diastolic blood pressure from baseline		6 months post-randomization	No
Other	Change in patient-recorded home systolic/diastolic blood pressure from baseline		6 months post-randomization	No
Other	Incidences of achieving reductions of = 5 mmHg, = 10 mmHg, =15 mmHg, and = 20 mmHg in blood pressure, including ambulatory, office and home blood pressure		6 months post-randomization	No
Other	Incidences of substantially adjusting antihypertensive medications	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.	6 months post-randomization	No
Primary	Change in average 24-hour systolic blood pressure by ambulatory blood pressure monitoring from baseline		3 months post-randomization	No
Secondary	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	6 months post-randomization	No
Secondary	Change in daytime and nighttime ambulatory systolic blood pressure from baseline		3 months post-randomization	No
Secondary	Change in 24 hour average, daytime and nighttime ambulatory diastolic blood pressure from baseline		3 months post-randomization	No
Secondary	Change in serum creatinine from baseline		6 months post-randomization	Yes
Secondary	Incidence of adverse event		Through study completion, up to 6 months	Yes