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Active, not recruiting Not applicable

A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension

NCT06216808 · tracked via the Priya Life Science South Korea tracker
Sponsor
DeepQure Inc
Phase
Not applicable
Started
2023-12-04
Last updated
2026-08-10

Condition(s) studied

Resistant Hypertension

Investigational drug(s) / intervention(s)

HyperQure Renal Denervation System

HyperQure Renal Denervation System: The HyperQure RDN System consists of a generator that generates RF energy and a Laparoscopic Instrument that delivers the RF energy generated by the generator to the treatment area. Through a laparoscopic approach, the renal artery is accessed through the retroperitoneum, which is the closest path to the renal artery. After wrapping 360 degrees of renal artery, RDN is performed as per the preset parameters of 50 degrees and 70 seconds. The target blood vessel is planned by CTA before the procedure, and the proximal and distal areas of the right and left main renal artery are treated once at a distance of at least 3 mm respectively, and RDN is also performed on the branch or accessory vessel confirmed to be suitable for the procedure by CTA.

Study summary

HQ-HTN-K01-02 is a prospective, multicenter, single arm, open label, first-in-human study to evaluate the safety and initial efficacy of HyperQureTM, laparoscopic denervation therapy, in patients with resistant hypertension on 3 or more antihypertensive medications

Eligibility

Sex
ALL
Min age
19 Years
Max age
79 Years
Healthy volunteers
No
Inclusion Criteria: Subjects are deemed eligible for this clinical trial only if they meet all of the following criteria: 1. Male and female patients aged between 19 and 79 years old 2. Resistant hypertensive patients on stable regimen of at least 3 antihypertensive medications\* for at least 4weeks prior Screening1 and those who are willing to continue existing antihypertensive medications during run- in period and till 3 months after surgery from Screening 1 * Patients on at least 3 antihypertensive medications of different classes including diuretics 3. Those who meet the following blood pressure requirements: \[Screening 1\] * Office systolic blood pressure (SBP) ≥ 140 mmHg * Office diastolic blood pressure (SBP) ≥ 90 mmHg \[Screening 2\] * Office SBP ≥ 140 mmHg * Office DBP ≥ 90 mmHg * Daytime ASBP ≥ 135 mmHg 4. Those who have the ability and willingness to provide voluntary and written consent to participate in this clinical trial Exclusion Criteria: Subjects cannot be enrolled in the clinical trial if they meet any of the following criteria 1. Those with the following confirmed anatomical findings in the kidney or renal artery that are unsuitable for renal denervation (assessed based on the results of the renal CT angiography of Screening 2) * If there is an atheroma or renal artery stent within 5 mm of the renal denervation site * Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy * When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator 2. Those with a medical history or a history of surgery/procedure that is unsuitable for renal denervation therapy * Renal denervation therapy * Renal artery stenting within 3 months prior to surgery * Polycystic kidney disease (PKD) * Atrophic kidney * Kidney transplant * Dialysis due to end-stage renal disease * Any surgery performed on the both kidney * FMD(Fibromuscular dysplasia) 3. Those with a confirmed comorbidity or a history of surgery/procedure that is unsuitable for posterior retroperitoneal approach required for renal denervation therapy * Surgical history using the retroperitoneal approach * Fibrosis of the retroperitoneal region * Inflammation of the retroperitoneal region * Extreme obesity (body mass index (BMI) \> 40 kg/m2) * Risk of elevated intracranial pressure 4. eGFR\* \< 45 mL/min/1.73 m2 * eGFR calculation formula (MDRD equation) 175 × (sCr)-1.154 × (age)-0.203 × (0.742 if female) 5. Those with type 1 diabetes or uncontrolled type 2 diabetes\* * Uncontrolled type 2 diabetes: HbA1c ≥ 8.0% * HbA1c will be tested in Screening 2 if the confirmed HbA1c result is from the test conducted 3 months before Screening 2 or if additional tests are deemed necessary according to the investigator discretion due to a history of inadequately controlled blood glucose level. 6. Those who receive SGLT2 inhibitors or GLP-1 agonists within 90 days before Screening 1, or those who are expected to require treatment during the clinical trial period(but if on continuous medication without changes more than 90days can be enrolled) 7. Those with at least a 20-mmHg decrease in office SBP or at least a 10-mmHg decrease in office DBP accompanied by symptoms, measured within 3 minutes of standing up during Screening 2(but if orthostatic hypotension is clearly due to Benign Prostatic Hyperplasia, subject can be enrolled) 8. Those who are likely to experience safety problems due to blood pressure drop according to the discretion of the investigator (e.g., heart valve stenosis, peripheral vascular disease, aortic aneurysm, and high-risk groups for bleeding (thrombocytopenia, hemophilia, severe anemia, etc.) 9. Those who have difficulty in measuring blood pressure accurately according to the discretion of the investigator (e.g., if the circumference of the upper arm is larger than the cuff size of the blood pressure monitor, those with arrhythmia, etc.) 10. Those who have secondary hypertension or are receiving sympathomimetic drugs that affect hypertension 11. Those with a history of the following cardiovascular diseases or accompanying diseases * Myocardial infarction occurring within 3 months prior to Screening 1 * Stable/Unstable angina occurring within 3 months prior to Screening 1 * Heart failure(NYHA classification III\~IV) within 3 months prior to Screening 1 * Transient ischemic attack within 3 months prior to Screening 1 * Cerebrovascular seizures (e.g., subarachnoid hemorrhage, cerebral embolism, etc.) within 3 months prior to Screening 1 * Atrial fibrillation (except for those who have confirmed sinus rhythm after undergoing medicinal treatment or surgery such as catheterization for the treatment of atrial fibrillation) 12. Those with primary pulmonary hypertension 13. Those with confirmed bleeding diathesis, coagulation disorder, or refusal to receive transfusions 14. Those with a history of peptic ulcer disease or gastrointestinal bleeding within 6 months prior to Screening 1 15. Those who are chronically on oxygen-assisted or mechanical ventilation (e.g., CPAP, BiPAP) (however, usage due to sleep apnea is exempted) 16. Those who have taken non-steroidal anti-inflammatory drugs (NSAIDs) twice or more per week for pain control within 1 month prior to Screening 2 17. Those with a history of contraindications to the use of contrast agents, anaphylactic reactions, or uncontrolled allergic reactions 18. Those receiving antiretroviral drug therapy due to HIV infection (except when there is a documented history of hypertension prior to initiation of antiretroviral drug therapy) 19. Those with the following confirmed drug administration history in relation to narcotic drugs: * A history of abuse of narcotic drugs * Those who use methadone * Those who have used narcotic drugs twice or more within 1 month prior to Screening 1 20. Those with drug or alcohol dependence that has not been cured at the time of Screening 1, and who lack the ability or are unable to understand and follow the instructions required in this clinical trial 21. Those who are scheduled to undergo a surgery/procedure that is expected to affect the efficacy and safety of this clinical trial according to the discretion of the investigator 22. Night shift workers 23. Those who have received other investigational products or investigational medical devices within 4 weeks prior to Screening 1 (however, such patients may be enrolled if such products of devises do not affect the efficacy and safety assessment of this clinical trial according to the discretion of the investigator) 24. Women who are pregnant, lactating, or plan to become pregnant during the period of the clinical trial 25. Other subjects who are deemed ineligible to participate in this clinical trial according to the investigator's discretion

Primary outcome measure(s)

  • Change in 24-h Ambulatory Systolic Blood Pressure(ASBP) — from baseline to 3 months post procedure
    Change in 24-h ASBP from baseline at 3 months post procedure

Trial sites (7)

FacilityCityRegionStatus
Chonnam National University Hospital Hwasun Hospital Jeonam Chonnam Province
Seoul National University Bundang Hospital Gyeonggi-do South Korea
Asan Medical Center Seoul South Korea
Hanyang University Seoul Hospital Seoul South Korea
Seoul National University Hospital Seoul South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital Seoul South Korea
Yonsei University Health System, Severance Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06216808 on ClinicalTrials.gov ↗ ← All trials in South Korea