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HypertensionNCT04307836

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

A study testing Renal Denervation in people with Hypertension and Vascular Diseases, run by Kalos Medical at 30 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
Renal Denervation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
30 sitesSouth Korea
Study dates
9 Jul 2020to 17 Apr 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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 ventilation (except for sleep apnea)
  • Subject with primary pulmonary hypertension

Trial locations and contacts

30 sites in 1 country.

EunHa Choi contact

82-2-527-5593

Eunha.Choi@kalosmedical.com

30 sites in 1 country

South Korea30 sites, 30 recruiting

  • Bucheon St.Mary's Hospital

    Bucheon-si

    Sang Hyun Ihm, MD

    Recruiting

  • Hyewon Medical Foundation Sejong General Hospital

    Bucheon-si

    Young Jin Choi, MD

    Recruiting

  • Inje University Busan Paik Hospital

    Busan

    Tae Hyun Yang, MD

    Recruiting

  • Chungbuk National University Hospital

    Cheongju-si

    Jang Whan Bae, MD

    Recruiting

  • Inje University Ilsan Paik Hospital

    Ilsan

    Sang Yun Lee, MD

    Recruiting

  • Gachon University Gil Medical Center

    Incheon

    Woong Chol Kang, MD

    Recruiting

  • Incheon St.Mary's Hospital

    Incheon

    Ik Jun Choi, MD

    Recruiting

  • Chonbuk National University Hospital

    Jeonju

    Sang Rok Lee, MD

    Recruiting

  • Chonnam National University Hospital

    Kwangju

    Ju Han Kim, MD

    Recruiting

  • Pusan National University Hospital

    Pusan

    Han Cheol Lee, MD

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si

    Dong Ju Choi, MD

    Recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Soon Jun Hong, MD

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Hae-young Lee, MD

    Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Byeong-Keuk Kim, MD

    Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

    Young Won Yoon, MD

    Recruiting

  • Asan Medical Center

    Seoul

    Pil Hyung Lee, MD

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul

    Wook Bum Pyun, MD

    Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul

    Jun Hee Lee, MD

    Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul

    Jung-Rae Cho, MD

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul

    Jin Ho Shin, MD

    Recruiting

  • Korea University Guro Hospital

    Seoul

    Cheol Ung Choi, MD

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul

    Jin Man Cho, MD

    Recruiting

  • Samsung Medical Center

    Seoul

    Seung Hyuk Choi, MD

    Recruiting

  • Seoul St. Mary's Hospital

    Seoul

    Ki Yuk Chang, MD

    Recruiting

  • Yeouido St.Mary's Hospital

    Seoul

    Chul Soo Park, MD

    Recruiting

  • St. Carollo Hospital

    Suncheon

    Jang Hyun Cho, MD

    Recruiting

  • St. Vincent's Hospital

    Suwon

    Ki Dong Yoo, MD

    Recruiting

  • Uijeongbu St.Mary's Hospital

    Uijeongbu-si

    Chan Joon Kim, MD

    Recruiting

  • Ulsan University Hospital

    Ulsan

    Eun-Seok Shin, MD

    Recruiting

  • Wonju Severance Christian Hospital

    Wŏnju

    SungGyun Ahn, MD

    Recruiting

Other trials in South Korea

About this study

Official title: A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

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.

Read the detailed description

DENEX system developed by Handok Kalos Medical Inc. is a renal denervation system to efficiently block the sympathetic nerve of the kidney with minimal invasive procedure. It was developed to block the sympathetic nerves distributed in blood vessel wall by delivering high frequency energy to the renal artery for the purpose of treating hypertension.

Being tested
Renal Denervation
Keywords
Hypertension, Renal Denervation, Uncontrolled hypertension
Medical subject headings
Hypertension, Vascular Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Renal DenervationDevice

    Renal Denervation: DENEX system

Study groups in NCT04307836
Study groupRoleWhat they receive
DENEX Renal denervationExperimentalSubjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications
Receives: Device: Renal Denervation
Control groupNo interventionSubjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in average daytime ambulatory systolic blood pressure at 3 months

    Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure

    Measured: from baseline at 3 months after the procedure

Secondary outcomes (3)

  1. Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months

    Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure

    Measured: from baseline at 3, 6 and 12 months after the procedure

  2. Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months

    Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure

    Measured: from baseline at 1, 3, 6 and 12 months after the procedure

  3. Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months

    Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure

    Measured: from baseline at 3, 6 and 12 months after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start9 Jul 2020
  3. Primary completion17 Jul 2023
  4. Study completion17 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307836
Sponsor's protocol ID
DN_P101
Status last verified
Feb 2023
First submitted
11 Mar 2020
Last updated
6 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Renal Denervation in people with Hypertension and Vascular Diseases, run by Kalos Medical at 30 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact EunHa Choi (82-2-527-5593, Eunha.Choi@kalosmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in average daytime ambulatory systolic blood pressure at 3 months (time frame: from baseline at 3 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04307836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.

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