UnknownNot Applicable

DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

Greece100 participantsStarted 2022-10-20

Plain-language summary

The objective of this study is to evaluate the safety and effectiveness of renal denervation using DENEX System in patients with hypertension without antihypertensive medication, compared with the sham group.

Who can participate

Age range

18 Years – 80 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 18 to 80 years old at the time of signing the informed consent
. Subject who is drug-naïve or willing to discontinue current antihypertensive treatment (not on antihypertensive medications for at least 4 weeks prior to Screening Visit 1) at Screening Visit 1 through the 3-month post-procedure visit. Drug-naïve is defined as those with no previous exposure to antihypertensive medications.
. Subject who meets all of the following blood pressure measurements:
. Subject who voluntarily decides to participate in this clinical study and sign the written consent.
. Subject who willing and able to complete all clinical investigation-related procedures and assessments

Exclusion criteria

. Subject with renal anatomy that is ineligible for treatment:
. Subject with prior renal denervation, renal artery stenting, renal artery angioplasty, renal nephrectomy, or renal transplant
. Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c over 10.0%)
. Subject with epidermal growth factor receptor (eGFR) \< 45 mL/min/1.73 m2, using the 4-variable modification of diet in renal disease (MDRD) clinical investigation calculation

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

Change in 24-h ambulatory systolic blood pressure

Timeframe: from baseline to 3 months post-procedure

Incidence of MAE within 3 months post-procedure

Timeframe: within 3 months post-procedure

Trial details

NCT IDNCT04535050

SponsorKalos Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-30

Contact for this trial

EunHa Choi

82-2-527-5417 eunha.choi@kalosmedical.com

View on ClinicalTrials.gov More Hypertension trials