Laparoscopic renal denervation therapy for resistant hypertension

A Prospective, Multicenter, Single Arm, Open Label, First-in-human Study to Evaluate the Safety and Initial Efficacy of HyperQureTM, Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on 3 or More Antihypertensive Medications

This study is testing a new procedure to see if it can help people with hard-to-treat high blood pressure who are already taking multiple medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 19 Years to 79 Years
• Sex: All
• Sponsor: DeepQure Inc. (Industry-sponsored)
• Locations: 7 sites (Jeonam, Chonnam Province and 6 other locations)
• Trial ID: NCT06216808 on ClinicalTrials.gov

What this trial studies

This interventional study evaluates the safety and initial efficacy of the HyperQureTM laparoscopic renal denervation therapy in patients suffering from resistant hypertension who are on three or more antihypertensive medications. The study aims to address limitations of traditional endovascular renal denervation by using a novel approach that targets renal sympathetic nerves through the adventitia, potentially achieving more complete denervation. A total of ten eligible adult participants will undergo the procedure under general anesthesia, with their blood pressure and quality of life monitored for 12 months post-treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19 to 79 with resistant hypertension who are on a stable regimen of at least three antihypertensive medications.

Not a fit: Patients who do not have resistant hypertension or those who are not on multiple antihypertensive medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with resistant hypertension, potentially improving their blood pressure control.

How similar studies have performed: While this approach is novel, previous studies on renal denervation have shown promise, indicating potential for success in this area.

Eligibility criteria

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

Where this trial is running

Jeonam, Chonnam Province and 6 other locations

• Chonnam National University Hospital Hwasun Hospital — Jeonam, Chonnam Province, South Korea (Recruiting)
• Seoul National University Bundang Hospital — Gyeonggi-do, South Korea (Recruiting)
• Asan Medical Center — Seoul, South Korea (Recruiting)
• Hanyang University Seoul Hospital — Seoul, South Korea (Recruiting)
• Seoul National University Hospital — Seoul, South Korea (Recruiting)
• The Catholic University of Korea, Seoul St. Mary's Hospital — Seoul, South Korea (Recruiting)
• Yonsei University Health System, Severance Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Principal investigator: SungHoo Hong, MD — The Catholic University of Korea
• Study coordinator: Aeyoung Woo

Conditions Resistant Hypertension