DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

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.

Study Overview

• Status: Completed
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Device: Renal denervation

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Seoul St.Mary's Hospital
  • Uijeongbu, Korea, Republic of
    • Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of all adverse events	rate of major adverse events for 1 month after the treatment	From baseline to 1 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	From baseline to 1, 3, 6, 12, 18, 24 months post-procedure

Collaborators and Investigators

• Sponsor: Kalos Medical
• Investigators: Principal Investigator: Yangsu Jang, Division of Cardiology, Severance Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2016
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): May 7, 2020

Study Registration Dates

• First Submitted: January 28, 2020
• First Submitted That Met QC Criteria: January 28, 2020
• First Posted (Actual): January 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Uncontrolled Hypertension; Renal Denervation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: DN_C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No