Actively Recruiting
A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
Led by DeepQure Inc. · Updated on 2025-12-04
10
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 19 to 79 years
- Diagnosed with resistant hypertension on a stable regimen of at least 3 antihypertensive medications including a diuretic for at least 4 weeks before screening
- Office systolic blood pressure of 140 mmHg or higher and diastolic blood pressure of 90 mmHg or higher at screening visits
- Daytime ambulatory systolic blood pressure of 135 mmHg or higher at screening
- Willing and able to provide written informed consent and continue current antihypertensive medications through 3 months after surgery
You will not qualify if you...
- Anatomical issues in kidney or renal artery unsuitable for denervation, such as atheroma or stent near treatment site, significant stenosis, or inability to treat both renal arteries
- History of renal denervation therapy, recent renal artery stenting, polycystic kidney disease, atrophic kidney, kidney transplant, dialysis, or kidney surgery
- Conditions preventing retroperitoneal laparoscopic approach, including prior surgeries, fibrosis, inflammation, extreme obesity (BMI > 40), or risk of elevated intracranial pressure
- Estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2
- Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c 8.0% or higher)
- Recent use of SGLT2 inhibitors or GLP-1 agonists within 90 days unless stable without changes
- Orthostatic hypotension with significant blood pressure drops unless due to benign prostatic hyperplasia
- Conditions posing safety risks from blood pressure drops, such as heart valve stenosis, peripheral vascular disease, aortic aneurysm, or bleeding disorders
- Difficulty measuring blood pressure accurately due to arm size or arrhythmia
- Secondary hypertension or use of sympathomimetic drugs affecting hypertension
- Recent cardiovascular events or severe heart conditions within 3 months
- Primary pulmonary hypertension
- Bleeding disorders or refusal of transfusions
- Recent peptic ulcer disease or gastrointestinal bleeding
- Chronic oxygen therapy or mechanical ventilation (except for sleep apnea)
- Frequent use of NSAIDs within 1 month
- Allergic reactions or contraindications to contrast agents
- Antiretroviral therapy for HIV started after hypertension diagnosis
- History of narcotic abuse or recent narcotic use
- Untreated drug or alcohol dependence
- Scheduled surgeries affecting study safety or efficacy
- Night shift workers
- Recent participation in other clinical trials affecting this study
- Pregnancy, lactation, or plans for pregnancy during the trial
- Any other conditions judged by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Chonnam National University Hospital Hwasun Hospital
Jeonam, Chonnam Province, South Korea
Actively Recruiting
2
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea
Actively Recruiting
4
Hanyang University Seoul Hospital
Seoul, South Korea
Actively Recruiting
5
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
6
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
7
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
A
Aeyoung Woo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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