DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

Uncontrolled Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04248530
• Other study ID #: DN_C101
• Status: Completed
• Phase: N/A
• Start date: November 30, 2016
• Est. completion date: May 7, 2020

Study information

• Verified date: May 2020
• Source: Kalos Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 7, 2020
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Uncontrolled Hypertension

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul St.Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Uijeongbu St. Mary's Hospital	Uijeongbu

Sponsors (1)

Lead Sponsor	Collaborator
Kalos Medical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all adverse events	rate of major adverse events for 1 month after the treatment	From baseline to 1 month post-procedure
Secondary	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
Secondary	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
Secondary	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