DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

Study Overview
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Brief Summary
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The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.

Detailed Description
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DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking 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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An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: Renal denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual is ≥ 20 years of age at time of consent Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months. Exclusion Criteria: Main renal artery contains renal artery stenosis >50% Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram Undergone prior renal angioplasty Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques Individual has Hemodynamically or echocardiography significant valvular heart disease Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension) Individual has documented primary pulmonary hypertension Individual has orthostatic hypotension with symptom Individual requires chronic oxygen support for sleep apnea Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention Individual has Type 1 diabetes mellitus

Ages Eligible for Study
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Minimum Age: 20 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal denervation therapy group<br>The subject treated by renal denervation by using DENEX system. | Device: Renal denervation<br>* DENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of all adverse events | rate of major adverse events for 1 month after the treatment | From baseline to 1 month post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ambulatory SBP change at 3,6,12,24 months | Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation | From baseline to 3, 6, 12, 24 months post-procedure | 
| Office SBP change at 1, 3, 6, 12, 18, 24 months | Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation | From baseline to 1, 3, 6, 12, 18, 24 months post-procedure | 
| Percentage of decreased office SBP >10, 15, 20 mmHg | Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation | From baseline to 1, 3, 6, 12, 18, 24 months post-procedure | 

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