RecruitingNot ApplicableNCT04535050

DENEX Renal Denervation in Patients With Hypertension on no Antihypertensive Medications

A Prospective, Multicenter, Sham-controlled, Single-blinded, Randomized, Pilot Study to Evaluate the Safety and Effectiveness of DENEX Renal Denervation System in Patients With Uncontrolled Hypertension Not Treated With Anti-HTN Medication


Sponsor

Kalos Medical

Enrollment

100 participants

Start Date

Oct 20, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a minimally invasive procedure called renal denervation — where nerves around the kidney arteries are deactivated using energy — as a way to lower blood pressure without relying on medication. **You may be eligible if...** - You are between 18 and 80 years old - You either have never taken blood pressure medication (drug-naïve) or are willing to stop taking it for the study period - Your blood pressure is elevated: office systolic reading between 150–180 mmHg, diastolic at least 90 mmHg, and 24-hour monitoring showing systolic readings of 140–170 mmHg - You are willing to have the procedure and follow-up visits **You may NOT be eligible if...** - You have secondary causes of high blood pressure (such as a hormone-secreting tumor) - You have severe kidney disease or only one working kidney - You have had a heart attack or stroke recently - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERenal denervation

Renal Denervation: DENEX system

PROCEDURERenal angiography

Renal angiography


Locations(1)

University of Athens Hippocratio Hospital

Athens, Greece

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NCT04535050


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