RECRUITING

Early Feasibility Study of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

HQ-HTN-G01 is a prospective, multicenter, single arm, open label, early feasibility study to evaluate initial safety and device design concept of "HyperQureTM RDN System", laparoscopic renal denervation therapy, in patients with resistant hypertension on three(3) or more antihypertensive medications

Official Title

A Prospective, Multicenter, Single Arm, Open-label, Early Feasibility Study to Evaluate Initial Safety and Device Design Concept of "HyperQureTM RDN System", Laparoscopic Renal Denervation Therapy, in Patients With Resistant Hypertension on Three(3) or More Antihypertensive Medications

Quick Facts

Study Start:2024-11-05

Study Completion:2028-05-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06526858

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Aged ≥22 and ≤80 years old at time of enrollment (consent). 2. Diagnosed with resistant hypertension. 3. Office BP ≥140/90 mmHg at Screening Visit 13, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent. 4. Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 23. 5. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.	1. Has coverage diameter of renal artery less than 2 mm or greater than 11 mm. 2. Has one or more of the following conditions: 1. Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment. 2. Myocardial infarction within 3 months of enrollment. 3. Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment 4. Cerebrovascular accident or transient ischemic attack within 3 months of enrollment. 5. Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded 3. Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2) 1. A single functioning kidney. 2. An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site. 3. Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy. 4. When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator. 4. Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy 1. Renal denervation therapy. 2. Polycystic kidney disease (PKD). 3. Atrophic kidney. 4. Kidney transplant. 5. Dialysis due to end-stage renal disease. 6. Any surgery performed on both kidneys. 7. FMD (Fibromuscular dysplasia) 5. Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach 1. Surgical history through retroperitoneal approach. 2. Fibrosis in the retroperitoneal region. 3. Inflammation in the retroperitoneal region. 4. Severe obesity (body mass index (BMI) \> 40 kg/m2) 5. Risk of increased intracranial pressure 6. Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty. 7. Individual has an eGFR of \<60 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female). 8. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%). 9. Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2). 10. Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP). 11. Has documented primary pulmonary hypertension. 12. Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension. 13. Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints. 14. Works night shifts. 15. Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated. 16. Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography). 17. Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study follow-up requirements. 18. Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions. 19. Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days. 20. Allergy, intolerance or contraindications to contrast medium. 21. Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious risk to health. 22. Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2. 23. Concurrent enrollment in any other investigational drug or device study(Participation in non-interventional Registries is acceptable).

Inclusion Criteria

Exclusion Criteria

1. Aged ≥22 and ≤80 years old at time of enrollment (consent).
2. Diagnosed with resistant hypertension.
3. Office BP ≥140/90 mmHg at Screening Visit 13, and on at least 3 antihypertensive medications of different classes including a diuretic for at least 4 weeks prior to consent.
4. Daytime ABP ≥135/85 mmHg after a four (4)-week run-in period at Screening Visit 23.
5. Agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this clinical study.

1. Has coverage diameter of renal artery less than 2 mm or greater than 11 mm.
2. Has one or more of the following conditions:
1. Unstable angina with stent implantation (percutaneous coronary intervention) within 3 months of enrolment.
2. Myocardial infarction within 3 months of enrollment.
3. Acute heart failure (New York Heart Association (NYHA) III-IV) within 3 months of enrollment
4. Cerebrovascular accident or transient ischemic attack within 3 months of enrollment.
5. Atrial fibrillation patients undergoing treatment and not in sinus rhythm. Notes: Patients who have received medical treatment, catheter or surgical treatment for atrial fibrillation and are in sinus rhythm are not excluded
3. Has one or more of the following confirmed anatomical findings in the kidney or renal artery that are not suitable for renal denervation (assessed by the renal CT angiography of Screening 2)
1. A single functioning kidney.
2. An atheroma, aneurysm or renal artery stent within 5 mm of the renal denervation site.
3. Presence of stenosis of 30% or more on all of the blood vessels available for renal denervation therapy.
4. When it is deemed impossible to perform denervation on both renal arteries according to the discretion of the investigator.
4. Has one or more of the following medical history or a history of surgery/procedure that is not suitable for renal denervation therapy
1. Renal denervation therapy.
2. Polycystic kidney disease (PKD).
3. Atrophic kidney.
4. Kidney transplant.
5. Dialysis due to end-stage renal disease.
6. Any surgery performed on both kidneys.
7. FMD (Fibromuscular dysplasia)
5. Has comorbidities or surgical/procedural history that are not suitable for retroperitoneal approach
1. Surgical history through retroperitoneal approach.
2. Fibrosis in the retroperitoneal region.
3. Inflammation in the retroperitoneal region.
4. Severe obesity (body mass index (BMI) \> 40 kg/m2)
5. Risk of increased intracranial pressure
6. Has a history of any intervention for underlying renal artery pathology including stenting or balloon angioplasty.
7. Individual has an eGFR of \<60 mL/min/1.73m2, using the 4 variable Modification of Diet in Renal Disease (MDRD) calculation (in mL/min) per 1.73 m2 = 175 x Serum Cr-1.154 x age-0.203 x 1.212 (if patient is black) x 0.742 (if female).
8. Type I diabetes mellitus or uncontrolled Type II diabetes (defined as a plasma Hb1Ac ≥ 9.0%).
9. Has had a reduction of SBP of ≥20 mm Hg or DBP of ≥10 mm Hg within 3 minutes of standing coupled with symptoms during the screening process (at Screening Visit 2).
10. Requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea (e.g., CPAP, BiPAP).
11. Has documented primary pulmonary hypertension.
12. Has an untreated secondary cause of hypertension (either known or suspected) or is taking drugs that increase sympathetic tone and could contribute to hypertension.
13. Has a scheduled or planned surgery that, in the opinion of the Investigator, may affect study endpoints.
14. Works night shifts.
15. Has severe cardiac valve stenosis for which, in the opinion of the Investigator, a significant reduction of blood pressure is contraindicated.
16. Is pregnant, nursing or planning to become pregnant during the course of the study follow-up (Note: Female participants of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to angiography).
17. Has a known unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely or unable, in the opinion of the Investigator, to comply with study follow-up requirements.
18. Has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
19. Patients who are at high risk if taken off their anticoagulant and antiplatelet agents for a few days.
20. Allergy, intolerance or contraindications to contrast medium.
21. Prescribed any standard antihypertensive cardiovascular medication for other chronic conditions (e.g. ischemic heart disease) for less than 90 days before Screening visit 1 and whose discontinuation might pose serious risk to health.
22. Has frequent intermittent or chronic pain that results in the treatment with non-steroidal anti-inflammatory drugs (NSAIDs) for two (2) or more days per week over the month prior to Screening Visit 2.
23. Concurrent enrollment in any other investigational drug or device study(Participation in non-interventional Registries is acceptable).

Contacts and Locations

Study Contact

Aeyoung Woo

CONTACT

82 10 7109 0205

aywoo@deepqure.com

Jaehung Jung, MD

CONTACT

82 10 8885 4689

jhjung@deepqure.com

Study Locations (Sites)

University of Arizona Department of Urology

Tucson, Arizona, 85719

United States

University of California Irvine

Orange, California, 92868

United States

Stanford Health Care

Stanford, California, 94305

United States

Emory University Medical Center

Atlanta, Georgia, 30303

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: DeepQure Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-05

Study Completion Date2028-05-18

Study Record Updates

Study Start Date2024-11-05

Study Completion Date2028-05-18

Terms related to this study

Additional Relevant MeSH Terms

Resistant Hypertension