NCT04248530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2020

Completed
Last Updated

June 22, 2022

Status Verified

May 1, 2020

Enrollment Period

2.6 years

First QC Date

January 28, 2020

Last Update Submit

June 19, 2022

Conditions

Uncontrolled Hypertension

Keywords

Uncontrolled HypertensionRenal Denervation

Outcome Measures

Primary Outcomes (1)

  • Rate of all adverse events

    rate of major adverse events for 1 month after the treatment

    From baseline to 1 month post-procedure

Secondary Outcomes (3)

  • Ambulatory SBP change at 3,6,12,24 months

    From baseline to 3, 6, 12, 24 months post-procedure

  • Office SBP change at 1, 3, 6, 12, 18, 24 months

    From baseline to 1, 3, 6, 12, 18, 24 months post-procedure

  • Percentage of decreased office SBP >10, 15, 20 mmHg

    From baseline to 1, 3, 6, 12, 18, 24 months post-procedure

Study Arms (1)

Renal denervation therapy group

EXPERIMENTAL

The subject treated by renal denervation by using DENEX system.

Device: Renal denervation

Interventions

Renal denervationDEVICE

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.

Renal denervation therapy group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individual is ≥ 20 years of age at time of consent
  • Individual has office systolic blood pressure (SBP) of ≥ 150 mmHg
  • Individual has daytime 24-hour Ambulatory Blood Pressure Monitoring (ABPM) SBP of ≥ 140 mmHg
  • 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.

You may not qualify if:

  • Main renal artery contains renal artery stenosis \>50%
  • Individual has confirmed anatomical findings in kidneys or renal arteries through CT scan or angiogram
  • Undergone prior renal angioplasty
  • Main renal arterial vessel for each kidney \<4 and \>8 mm in diameter, or \<20 mm length
  • Individual has an Estimated glomerular filtration rate \<45 mL/min/1.73 m2 at screening visit
  • 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
  • Individual has Hemodynamically or echocardiography significant valvular heart disease
  • Individual has secondary hypertension (pheochromocytoma, Cushing syndrome,coarctation of the aorta, renovascular hypertension, primary hyperaldosteronism, or other secondary hypertension)
  • Individual has documented primary pulmonary hypertension
  • Individual has orthostatic hypotension with symptom
  • Individual requires chronic oxygen support for sleep apnea
  • Individual is taking chronic NSAIDs (Non-Steroidal Anti-Inflammatory Drugs). Only, Aspirin is permitted for cardiovascular disease prevention
  • Individual has Type 1 diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pusan National University Hospital

Pusan, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Seoul St.Mary's Hospital

Seoul, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33377328DERIVED

Study Officials

  • Yangsu Jang

    Division of Cardiology, Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

November 30, 2016

Primary Completion

July 1, 2019

Study Completion

May 7, 2020

Last Updated

June 22, 2022

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(5)