DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

• Sponsor: Kalos Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04248530
• Collaborator: (none)
• Enrollment: 16
• Locations: 5
• Arm: 1
• Actual Duration (Months): 41.2
• Patients Per Site: 3.2
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uncontrolled Hypertension	Device: Renal denervation	N/A

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

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 30, 2016
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: May 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Renal denervation therapy group The subject treated by renal denervation by using DENEX system.	Device: Renal denervation; 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.

Outcome Measures

Primary Outcome Measures

1. Rate of all adverse events [From baseline to 1 month post-procedure]

   rate of major adverse events for 1 month after the treatment

Secondary Outcome Measures

1. Ambulatory SBP change at 3,6,12,24 months [From baseline to 3, 6, 12, 24 months post-procedure]

   Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation

2. Office SBP change at 1, 3, 6, 12, 18, 24 months [From baseline to 1, 3, 6, 12, 18, 24 months post-procedure]

   Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation

3. Percentage of decreased office SBP >10, 15, 20 mmHg [From baseline to 1, 3, 6, 12, 18, 24 months post-procedure]

   Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Individual is ≥ 20 years of age at time of consent

2. Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg

3. Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg

4. 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.

Exclusion Criteria:

1. Main renal artery contains renal artery stenosis >50%

2. Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram

3. Undergone prior renal angioplasty

4. Main renal arterial vessel for each kidney <4 and >8 mm in diameter, or <20 mm length

5. Individual has an Estimated glomerular filtration rate <45 mL/min/1.73 m2 at screening visit

6. 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

7. Individual has Hemodynamically or echocardiography significant valvular heart disease

8. Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)

9. Individual has documented primary pulmonary hypertension

10. Individual has orthostatic hypotension with symptom

11. Individual requires chronic oxygen support for sleep apnea

12. Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention

13. Individual has Type 1 diabetes mellitus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital	Pusan		Korea, Republic of
2	Severance Hospital	Seoul		Korea, Republic of	03722
3	Korea University Guro Hospital	Seoul		Korea, Republic of
4	Seoul St.Mary's Hospital	Seoul		Korea, Republic of
5	Uijeongbu St. Mary's Hospital	Uijeongbu		Korea, Republic of

Sponsors and Collaborators

• Kalos Medical

Investigators

• Principal Investigator: Yangsu Jang, Division of Cardiology, Severance Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kalos Medical
• ClinicalTrials.gov Identifier: NCT04248530
• Other Study ID Numbers: DN_C101
• First Posted: Jan 30, 2020
• Last Update Posted: Jun 22, 2022
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kalos Medical: Uncontrolled Hypertension; Renal Denervation
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Jun 22, 2022