Grade 1, Hypertension
Conditions
Keywords
hypertension, renal denervation, grade I
Brief summary
Prospective, Multi-Center, Randomized, shame-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radio-frequency（RF) renal denervation system-comprising the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines.
Detailed description
The six-channel RF renal denervation system, consisting of the six-channel RF generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding RF denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery RF denervation. This Prospective, Multi-Center, Randomized, shame-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with grade I hypertension and without taking antihypertensive medicines, and to provide clinical evidence supporting the expansion of indications. The trial will be conducted by the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Administration of Medical Device Registration and Filing, the Good Clinical Practice for Medical Devices, and other applicable requirements.
Interventions
DSA-guided percutaneous renal sympathetic denervation using a six-channel RF renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)
Sham procedure including femoral artery puncture and selective renal angiography; the six-channel radiofrequency generator is connected to a dummy load and produces activation sounds, but no energy is delivered. Minimum table time before sheath removal is 35 minutes.
Sponsors
Ruijin Hospital
Guangdong Provincial People's Hospital
Shanghai Tongji Hospital, Tongji University School of Medicine
Shandong First Medical University
Shanghai Institute of Hypertension
Shanghai Golden Leaf MedTec Co. Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female, aged 18 to 65 years inclusive 2. Hypertension duration longer than 3 months 3. Hypertensive subjects who have been stopped taking antihypertensive drugs continuously and stably for at least 4 weeks or who do not take antihypertensive drugs , with office systolic/diastolic blood pressure still ≥140/90 mmHg and \<160/100 mmHg, and 24-hour ambulatory mean systolic /diastolic pressure ≥130/80 mmHg and \<140/90 mmHg; 4. The subject or his/her legal representative fully understands the content of the informed consent form for this trial and voluntarily signs the written informed consent form.
Exclusion criteria
1. Pregnant or breastfeeding, or planning pregnancy during the study. 2. Renal artery anatomy unsuitable for ablation (e.g., ≥50% stenosis, renal artery aneurysm, malformation, renal artery diameter \<3 mm, or treatable segment length \<20 mm). 3. Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR\<40mL/min/1.73m2。 4. Other secondary hypertension not related to kidney disease (such as primary aldosteronism, pheochromocytoma/paraganglioma, Cushing's syndrome, thyroid disease, aortic coarctation, monogenic hypertension, renovascular hypertension, etc.). 5. Allergic to contrast agents. 6. Major surgery or trauma within 1 month before enrollment; acute coronary syndrome within 6 months; or planned surgery or cardiovascular interventional therapy within the next 6 months. 7. Orthostatic hypotension. 8. Type 1 diabetes mellitus. 9. History of bleeding diathesis and haematological disorders or coagulopathy 10. History of thromboembolic event within 6 months. 11. History of stroke or transient ischemic attack (TIA) within 6 months. 12. Severe peripheral arterial disease or unstable abdominal aortic aneurysm. 13. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months. 14. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker. 15. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS. 16. Acute or severe systemic infection. 17. Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups. | 3 months | the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM) | Baseline to 3 Months | 24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring; |
| Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg | Months 3 post-procedure | 24-hour mean BP measured by validated ambulatory BP monitoring; |
| Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP) | Baseline to Months 3 post-procedure | measured by validated office blood pressure monitoring |
| Change from Baseline in Antihypertensive Medication Use | Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure | Change in the number of concurrently prescribed antihypertensive agents |
| change from baseline in the time in target range of 24 hour ambulatory blood pressure | Months 3 post-procedure | 24-hour mean BP measured by validated ambulatory BP monitoring; |
Contacts
CONTACTJian-Zhong Xu, M.D. Ph.D
Outcome results
None listed