About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Subject aged 19 to 75 years old
2. 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
3. Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening
4. 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

1. Subject with the anatomical findings in kidney or renal artery which preclude renal denervation
2. Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus
3. Subject with eGFR less than 40mL/min/1.73㎡
4. Subject with a brachial circumference greater than 42 cm.
5. Subject with secondary hypertension (except for sleep apnea patients)
6. 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.
7. 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.
8. Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
9. Subject with primary pulmonary hypertension

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.