Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Keywords
Hypertension, Renal Denervation, Uncontrolled hypertension
Brief summary
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
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.
Interventions
DEVICERenal Denervation
Renal Denervation: DENEX system
Sponsors
Kalos Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in average daytime ambulatory systolic blood pressure at 3 months | from baseline at 3 months after the procedure | Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months | from baseline at 3, 6 and 12 months after the procedure | Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure 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 | from baseline at 1, 3, 6 and 12 months after the procedure | Changes in average office systolic blood pressure and diastolic blood pressure 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 | from baseline at 3, 6 and 12 months after the procedure | 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 |
Countries
South Korea
Contacts
Primary ContactEunHa Choi
Outcome results
None listed