DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

NCT ID: NCT04248530

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-05-07

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal denervation therapy group

The subject treated by renal denervation by using DENEX system.

Group Type: EXPERIMENTAL

Renal denervation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kalos Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yangsu Jang

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Severance Hospital

Locations

Pusan National University Hospital

Pusan, , South Korea

Severance Hospital

Seoul, , South Korea

Korea University Guro Hospital

Seoul, , South Korea

Seoul St.Mary's Hospital

Seoul, , South Korea

Uijeongbu St. Mary's Hospital

Uijeongbu-si, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 33377328 (View on PubMed)

Other Identifiers

DN_C101

Identifier Type: -

Identifier Source: org_study_id