DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study
- Conditions
- Uncontrolled Hypertension
- Interventions
- Device: Renal denervation
- Registration Number
- NCT04248530
- Lead Sponsor
- Kalos Medical
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal denervation therapy group Renal denervation The subject treated by renal denervation by using DENEX system.
- Primary Outcome Measures
Name Time Method Rate of all adverse events From baseline to 1 month post-procedure rate of major adverse events for 1 month after the treatment
- Secondary Outcome Measures
Name Time Method Percentage of decreased office SBP >10, 15, 20 mmHg From baseline to 1, 3, 6, 12, 18, 24 months post-procedure Percentage of subjects decreased office systolic blood pressure \> 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation
Office SBP change at 1, 3, 6, 12, 18, 24 months From baseline to 1, 3, 6, 12, 18, 24 months post-procedure Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation
Ambulatory SBP change at 3,6,12,24 months From baseline to 3, 6, 12, 24 months post-procedure Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation
Trial Locations
- Locations (5)
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St.Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Uijeongbu St. Mary's Hospital
🇰🇷Uijeongbu, Korea, Republic of