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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307836
• Other study ID #: DN_P101
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: April 17, 2024

Study information

• Verified date: February 2023
• Source: Kalos Medical
• Contact: EunHa Choi
• Phone: 82-2-527-5593
• Email: Eunha.Choi[@]kalosmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 17, 2024
• Est. primary completion date: July 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Vascular Diseases

Intervention

Device:
• Renal Denervation
Renal Denervation: DENEX system

Locations

Country	Name	City	State
Korea, Republic of	Bucheon St.Mary's Hospital	Bucheon
Korea, Republic of	Hyewon Medical Foundation Sejong General Hospital	Bucheon
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	Inje University Ilsan Paik Hospital	Ilsan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Incheon St.Mary's Hospital	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Chonnam National University Hospital	Kwangju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Seoul Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Yeouido St.Mary's Hospital	Seoul
Korea, Republic of	St. Carollo Hospital	Suncheon
Korea, Republic of	St. Vincent's Hospital	Suwon
Korea, Republic of	Uijeongbu St.Mary's Hospital	Uijeongbu
Korea, Republic of	Ulsan University Hospital	Ulsan
Korea, Republic of	Wonju Severance Christian Hospital	Wonju

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	Changes in average daytime ambulatory systolic blood pressure at 3 months	Changes in average daytime ambulatory systolic blood pressure from baseline at 3 months after the procedure	from baseline at 3 months after the procedure
Secondary	Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months	Changes in average 24hr ambulatory systolic blood pressure and diastolic blood pressure from baseline at 3, 6 and 12 months after the procedure	from baseline at 3, 6 and 12 months after the procedure
Secondary	Changes in average office systolic blood pressure and diastolic blood pressure at 1, 3, 6 and 12 months	Changes in average office systolic blood pressure and diastolic blood pressure from baseline at 1,3, 6 and 12 months after the procedure	from baseline at 1, 3, 6 and 12 months after the procedure
Secondary	Changes in average daytime and nighttime ambulatory systolic blood pressure and diastolic blood pressure at 3, 6 and 12 months	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	from baseline at 3, 6 and 12 months after the procedure