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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

254

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline

Completed

Started Oct 2016

Geographic Reach

1 country

13 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

First Submitted

Initial submission to the registry

September 7, 2016

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed

17 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 7, 2016

Last Update Submit

September 9, 2016

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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

Other Outcomes (5)

Change in 24 hour average, daytime and nighttime ambulatory systolic/diastolic blood pressure from baseline
6 months post-randomization
Change in office systolic/diastolic blood pressure from baseline
6 months post-randomization
Change in patient-recorded home systolic/diastolic blood pressure from baseline
6 months post-randomization
+2 more other outcomes

Study Arms (2)

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

Device: Radiofrequency ablation catheterDrug: 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.

Drug: Amlodipine, losartan potassium and hydrochlorothiazide

Interventions

Radiofrequency ablation catheterDEVICE

Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.

Renal Denervation plus Medications

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.

MedicationsRenal Denervation plus Medications

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai WiseGain Medical Devices Co., Ltd.lead

Study Sites (13)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Zhongshan Hospital affiliated to Fu Dan University

Shanghai, Shanghai Municipality, 200032, China

Location

Changhai Hospital affiliated to Second Military Medical University