Uncontrolled Hypertension
Conditions
Keywords
Uncontrolled Hypertension, Renal Denervation
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.
Interventions
DEVICERenal denervation
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.
Sponsors
Kalos Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Individual is ≥ 20 years of age at time of consent 2. Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg 3. Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg 4. 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
1. Main renal artery contains renal artery stenosis \>50% 2. Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram 3. Undergone prior renal angioplasty 4. Main renal arterial vessel for each kidney \<4 and \>8 mm in diameter, or \<20 mm length 5. Individual has an Estimated glomerular filtration rate \<45 mL/min/1.73 m2 at screening visit 6. 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 7. Individual has Hemodynamically or echocardiography significant valvular heart disease 8. Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension) 9. Individual has documented primary pulmonary hypertension 10. Individual has orthostatic hypotension with symptom 11. Individual requires chronic oxygen support for sleep apnea 12. Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention 13. Individual has Type 1 diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of all adverse events | From baseline to 1 month post-procedure | rate of major adverse events for 1 month after the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed