Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

Shanghai WiseGain Medical Devices

Status and phase: Unknown; Phase 3

Conditions: Hypertension

Treatments: Drug: Amlodipine, losartan potassium and hydrochlorothiazide; Device: Radiofrequency ablation catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02900729

WiseGo-CT-1601

Details and patient eligibility

About

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.

Enrollment: 254 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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254 participants in 2 patient groups

Renal Denervation plus Medications

Experimental group

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

Treatment:

Drug: Amlodipine, losartan potassium and hydrochlorothiazide

Device: Radiofrequency ablation catheter

Medications

Active Comparator group

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.

Treatment:

Drug: Amlodipine, losartan potassium and hydrochlorothiazide