Uncontrolled HypertensionNCT04248530
DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study
A study testing Renal denervation in people with Uncontrolled Hypertension, run by Kalos Medical at 5 sites in South Korea.
Trial summary
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Uncontrolled Hypertension
- 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
- 16 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 30 Nov 2016to 7 May 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual is ≥ 20 years of age at time of consent
- Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
- Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
- Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months.
Who cannot join
- Main renal artery contains renal artery stenosis >50%
- Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
- Undergone prior renal angioplasty
- Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length
- Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit
- Individual has experienced myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 3 months of the screening period, or has widespread atherosclerosis, with documented intravascular thrombosis or unstable plaques
Show all 13Show fewer
- Individual has Hemodynamically or echocardiography significant valvular heart disease
- Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)
- Individual has documented primary pulmonary hypertension
- Individual has orthostatic hypotension with symptom
- Individual requires chronic oxygen support for sleep apnea
- Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention
- Individual has Type 1 diabetes mellitus
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Pusan National University Hospital
Pusan
Severance Hospital
Seoul, 03722
Korea University Guro Hospital
Seoul
Seoul St.Mary's Hospital
Seoul
Uijeongbu St. Mary's Hospital
Uijeongbu-si
About this study
Official title: An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
Read the detailed description
DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking 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.
- Conditions
- Uncontrolled Hypertension
- Being tested
- Renal denervation
- Keywords
- Uncontrolled Hypertension, Renal Denervation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal denervationDevice
DENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle.
| Study group | Role | What they receive |
|---|---|---|
| Renal denervation therapy group | Experimental | The subject treated by renal denervation by using DENEX system. Receives: Device: Renal denervation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all adverse events
rate of major adverse events for 1 month after the treatment
Measured: From baseline to 1 month post-procedure
Secondary outcomes (3)
Ambulatory SBP change at 3,6,12,24 months
Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation
Measured: From baseline to 3, 6, 12, 24 months post-procedure
Office SBP change at 1, 3, 6, 12, 18, 24 months
Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation
Measured: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
Percentage of decreased office SBP >10, 15, 20 mmHg
Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation
Measured: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start30 Nov 2016
- Primary completion1 Jul 2019
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uncontrolled HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kalos Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yangsu Jang, Principal investigator, Division of Cardiology, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04248530
- Sponsor's protocol ID
- DN_C101
- Status last verified
- May 2020
- First submitted
- 28 Jan 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim CJ, Chang K, Kim BK, Park CG, Jang Y. An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX in Patients with Uncontrolled Hypertension on Standard Medical Therapy. Korean Circ J. 2021 Jan;51(1):43-55. doi: 10.4070/kcj.2020.0391.
PubMed 33377328
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Arm, Multicenter Feasibility Study to Evaluate the Safety of Catheter-Based Renal Denervation With the DENEX System in Patients With Uncontrolled Hypertension on Standard Medical Therapy
- ClinicalTrials.gov ID
- NCT04248530
- Acronym / sponsor ID
- DN_C101
- Conditions
- Uncontrolled Hypertension
- Keywords
- Uncontrolled Hypertension, Renal Denervation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Kalos MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is the multicenter pilot study to obtain an assessment of the safety of renal denervation in the patients with uncontrolled hypertension on standard medical therapy in Korea.
Detailed description
DENEX system developed by Handok Kalos Medical Inc. is a renal nerve blocking 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal denervation therapy group | Experimental | Device: Renal denervationThe subject treated by renal denervation by using DENEX system. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individual is ≥ 20 years of age at time of consent
- Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
- Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
- Individual maintains the following 3 antihypertensive medications: thiazide-type diuretic, calcium-channel blocker, and angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (for at least 6 weeks before the screening visit) that is expected to be maintained without changes for at least 6 months.
Key exclusion criteria (13 listed)
- Main renal artery contains renal artery stenosis >50%
- Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
- Undergone prior renal angioplasty
- Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length
- Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal denervationDENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle. | Device | Renal denervation therapy group |
Primary outcome
Rate of all adverse events
Time frame: From baseline to 1 month post-procedure
rate of major adverse events for 1 month after the treatment
3 secondary outcomes
Ambulatory SBP change at 3,6,12,24 months
Time frame: From baseline to 3, 6, 12, 24 months post-procedure
Office SBP change at 1, 3, 6, 12, 18, 24 months
Time frame: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
Percentage of decreased office SBP >10, 15, 20 mmHg
Time frame: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 33377328Kim CJ, Chang K, Kim BK, Park CG, Jang Y. An Open-label, Single-arm, Multicenter Feasibility Study Evaluating the Safety of Catheter-based Renal Denervation with DENEX in Patients with Uncontrolled Hypertension on Standard Medical Therapy. Korean Circ J. 2021 Jan;51(1):43-55. doi: 10.4070/kcj.2020.0391.
- Individual participant dataSharing planned: No
Related trials for Uncontrolled Hypertension
Active, not recruitingPhase 3
Open-Label Extension (OLE) Study to Assess Safety, Efficacy, and Tolerability of Lorundrostat in Subjects With Hypertension
Hypertension
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
RecruitingPhase 2
A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension
Uncontrolled Hypertension
Recruiting
Effectiveness and Cost-Effectiveness of a Digital Care Pathway and Asynchronous Communication for Patients With Hypertension
Hypertension
RecruitingPhase 2/3
A Trial of HRS-1780 in Participants With Uncontrolled Hypertension or Resistant Hypertension.
Uncontrolled or Resistant Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yangsu Jang principal investigator
Division of Cardiology, Severance Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal denervation in people with Uncontrolled Hypertension, run by Kalos Medical at 5 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 13 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: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all adverse events (time frame: From baseline to 1 month post-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 NCT04248530, which also lists 1 linked publication.
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 22 Jun 2022.