DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Med… (NCT04307836) | Clinical Trial Compass
UnknownNot Applicable
DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
South Korea140 participantsStarted 2020-07-09
Plain-language 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.
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ventil…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in average daytime ambulatory systolic blood pressure at 3 months
Timeframe: from baseline at 3 months after the procedure