DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

Study Overview
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Brief Summary
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The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.

Detailed Description
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DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Official Title
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A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Renal Denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject aged 19 to 75 years old Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks Exclusion Criteria: Subject with the anatomical findings in kidney or renal artery which preclude renal denervation Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus Subject with eGFR less than 40mL/min/1.73㎡ Subject with a brachial circumference greater than 42 cm. Subject with secondary hypertension (except for sleep apnea patients) Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment. Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent. Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea) Subject with primary pulmonary hypertension

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DENEX Renal denervation<br>Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications | Device: Renal Denervation<br>* Renal Denervation: DENEX system<br>|
| No Intervention: Control group<br>Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in average daytime ambulatory systolic blood pressure at 3 months | Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure | from baseline at 3 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months | Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure | from baseline at 3, 6 and 12 months after the procedure | 
| Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months | Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure | from baseline at 1, 3, 6 and 12 months after the procedure | 
| Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months | Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure | from baseline at 3, 6 and 12 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Renal Denervation, Uncontrolled hypertension