DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications

• Sponsor: Kalos Medical (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04307836
• Collaborator: (none)
• Enrollment: 140
• Locations: 30
• Arms: 2
• Anticipated Duration (Months): 42.7
• Patients Per Site: 4.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this study is to show that the safety and efficacy of renal denervation using DENEX, are superior to those of control group for the patients with hypertension on no or 1 to 3 antihypertensive medications.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Vascular Diseases; Cardiovascular Diseases	Device: Renal Denervation	N/A

Detailed Description

DENEX system developed by Handok Kalos Medical Inc. is a renal denervation 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
• Anticipated Enrollment: 140 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, No-treatment Controlled, Randomized, Open-label, Pivotal Study to Evaluate the Safety and Efficacy of DENEX, Renal Denervation Therapy, in Patients With Hypertension on no or 1-3 Antihypertensive Medications
• Actual Study Start Date: Jul 9, 2020
• Anticipated Primary Completion Date: Mar 30, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DENEX Renal denervation Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications	Device: Renal Denervation; Renal Denervation: DENEX system
No Intervention: Control group Subjects are not treated with the renal denervation, not sham, after randomization and maintained baseline anti-hypertensive medications

Outcome Measures

Primary Outcome Measures

1. Changes in average daytime ambulatory systolic blood pressure at 3 months [from baseline at 3 months after the procedure]

   Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure

Secondary Outcome Measures

1. Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months [from baseline at 3, 6 and 12 months after the procedure]

   Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure

2. Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months [from baseline at 1, 3, 6 and 12 months after the procedure]

   Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure

3. Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months [from baseline at 3, 6 and 12 months after the procedure]

   Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject aged 19 to 75 years old

• Subject should maintain the 0 to 3 antihypertensive medications of different classes, ACE-I, ARB, beta blocker, CCB or diuretics, without change for at least 4 weeks of run-in period between primary screening and secondary screening and for at least 3 months after the procedure

• Subject with 140 mmHg ≤ average office SBP < 180 mmHg and 90 mmHg ≤ office DBP < 120 mmHg at primary and secondary screening

• Subject with 135 mmHg ≤ average daytime ambulatory SBP <170 mmHg and 85 mmHg ≤ average daytime ambulatory DBP < 105 mmHg at secondary screening after the run-in period for at least 4 weeks

Exclusion Criteria:

• Subject with the anatomical findings in kidney or renal artery which preclude renal denervation

• Subject with type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus

• Subject with eGFR less than 40mL/min/1.73㎡

• Subject with a brachial circumference greater than 42 cm.

• Subject with secondary hypertension (except for sleep apnea patients)

• Subject with a medical history of cerebrovascular disease or severe cardiovascular disease within 12 months prior to obtaining the consent or patients newly diagnosed with such diseases before enrollment.

• Subject rehospitalized two or more times for hypertensive crisis within 12 months prior to obtaining consent or hospitalized for hypertensive crisis within three months prior to obtaining consent.

• Subject with chronic oxygen therapy or mechanical ventilation (except for sleep apnea)

• Subject with primary pulmonary hypertension

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bucheon St.Mary's Hospital	Bucheon		Korea, Republic of
2	Hyewon Medical Foundation Sejong General Hospital	Bucheon		Korea, Republic of
3	Inje University Busan Paik Hospital	Busan		Korea, Republic of
4	Chungbuk National University Hospital	Cheongju-si		Korea, Republic of
5	Inje University Ilsan Paik Hospital	Ilsan		Korea, Republic of
6	Gachon University Gil Medical Center	Incheon		Korea, Republic of
7	Incheon St.Mary's Hospital	Incheon		Korea, Republic of
8	Chonbuk National University Hospital	Jeonju		Korea, Republic of
9	Chonnam National University Hospital	Kwangju		Korea, Republic of
10	Pusan National University Hospital	Pusan		Korea, Republic of
11	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of
12	Korea University Anam Hospital	Seoul		Korea, Republic of	02841
13	Seoul National University Hospital	Seoul		Korea, Republic of	03080
14	Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	03722
15	Gangnam Severance Hospital, Yonsei University Health System	Seoul		Korea, Republic of	06273
16	Asan Medical Center	Seoul		Korea, Republic of
17	Ewha Womans University Seoul Hospital	Seoul		Korea, Republic of
18	Hallym University Kangdong Sacred Heart Hospital	Seoul		Korea, Republic of
19	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of
20	Hanyang University Seoul Hospital	Seoul		Korea, Republic of
21	Korea University Guro Hospital	Seoul		Korea, Republic of
22	Kyung Hee University Hospital at Gangdong	Seoul		Korea, Republic of
23	Samsung Medical Center	Seoul		Korea, Republic of
24	Seoul St. Mary's Hospital	Seoul		Korea, Republic of
25	Yeouido St.Mary's Hospital	Seoul		Korea, Republic of
26	St. Carollo Hospital	Suncheon		Korea, Republic of
27	St. Vincent's Hospital	Suwon		Korea, Republic of
28	Uijeongbu St.Mary's Hospital	Uijeongbu		Korea, Republic of
29	Ulsan University Hospital	Ulsan		Korea, Republic of
30	Wonju Severance Christian Hospital	Wŏnju		Korea, Republic of

Sponsors and Collaborators

• Kalos Medical

Investigators

• Principal Investigator: Ki Yuk Chang, MD, Ph.D, Seoul St. Mary's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kalos Medical
• ClinicalTrials.gov Identifier: NCT04307836
• Other Study ID Numbers: DN_P101
• First Posted: Mar 13, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Nov 1, 2021

• 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: Hypertension; Renal Denervation; Uncontrolled hypertension
• Additional relevant MeSH terms: Hypertension; Cardiovascular Diseases; Vascular Diseases

Study Results

No Results Posted as of Aug 18, 2022