Clinical trial NCT04248530: DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uncontrolled Hypertension
Keywords: Uncontrolled Hypertension
Renal Denervation
Lead sponsor: Kalos Medical
Sponsor class: INDUSTRY
First posted: 2020-01-30
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of all adverse events
timeFrame: From baseline to 1 month post-procedure
Secondary outcomes:
measure: Ambulatory SBP change at 3,6,12,24 months
timeFrame: From baseline to 3, 6, 12, 24 months post-procedure
measure: Office SBP change at 1, 3, 6, 12, 18, 24 months
timeFrame: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
measure: Percentage of decreased office SBP >10, 15, 20 mmHg
timeFrame: From baseline to 1, 3, 6, 12, 18, 24 months post-procedure
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
Study officials:
affiliation: Division of Cardiology, Severance Hospital
name: Yangsu Jang
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.