For Healthcare Professionals

DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications


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
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Hypertension,Vascular Diseases,Cardiovascular Diseases

Age (in years)

19 - 75


Not Applicable

Participants needed


Est. Completion Date

Apr 17, 2024

Treatment type



Kalos Medical identifier


Study number


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