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Completed

NCT Number: NCT04248530

DENEX Renal Denervation in Patients With Uncontrolled Hypertension: Safety Study

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.

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Key information

Conditions

Uncontrolled Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Hospital, Pusan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Renal Denervation

Device

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.

Primary outcomes

  1. Rate of all adverse events

    Time frame: From baseline to 1 month post-procedure

    rate of major adverse events for 1 month after the treatment

Secondary outcomes

  1. Ambulatory SBP change at 3,6,12,24 months

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

    Change in systolic blood pressure as measured by 24-hour ABPM at 3, 6, 12, 24 months post denervation

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

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

    Change in office systolic blood pressure at 1, 3, 6, 12, 18, 24 months post denervation

  3. Percentage of decreased office SBP >10, 15, 20 mmHg

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

    Percentage of subjects decreased office systolic blood pressure > 10 mmHg, 15 mmHg, 20 mmHg at 1, 3, 6, 12, 18, 24 months post denervation

Sponsors and collaborators

Lead sponsor

Kalos Medical

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jan 30, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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