A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Re… (NCT06216808) | Clinical Trial Compass
RecruitingNot Applicable
A First-in-human Study of HyperQureTM", Laparoscopic Renal Denervation Therapy in Patient With Resistant Hypertension
South Korea10 participantsStarted 2023-12-04
Plain-language 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
Who can participate
Age range19 Years – 79 Years
SexALL
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Inclusion criteria
✓. Male and female patients aged between 19 and 79 years old
✓. 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
✓. Those who meet the following blood pressure requirements:
✓. Those who have the ability and willingness to provide voluntary and written consent to participate in this clinical trial
Exclusion criteria
✕. 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)
✕. Those with a medical history or a history of surgery/procedure that is unsuitable for renal denervation therapy
✕. Those with a confirmed comorbidity or a history of surgery/procedure that is unsuitable for posterior retroperitoneal approach required for renal denervation therapy
✕. eGFR\* \< 45 mL/min/1.73 m2
✕. Those with type 1 diabetes or uncontrolled type 2 diabetes\*
✕. 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)
What they're measuring
1
Change in 24-h Ambulatory Systolic Blood Pressure(ASBP)
Timeframe: from baseline to 3 months post procedure
✕. 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)
✕. 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.)