CKD - Chronic Kidney Disease, Hypertension
Conditions
Keywords
Uncontrolled Hypertension, CKD, RDN
Brief summary
Prospective, Multi-Center, Randomized, Parallel-Controlled, Uptake clinical trial to evaluate the efficacy and safety of the six-channel radiofrequency（RF) renal denervation system-comprising the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T)-for renal denervation in patients with uncontrolled hypertension and chronic kidney disease.
Detailed description
The six-channel RF renal denervation system, consisting of the six-channel radiofrequency generator (specification model: 25D1G, software release version: SRG-V1) and the disposable ultra-guiding radiofrequency denervation catheter (specification model: 25C6W127F115T), is designed and manufactured by Shanghai Golden Leaf MedTec Co., Ltd (BRATTEA) for renal artery radiofrequency denervation. This Prospective, Multi-Center, Randomized, parallel-controlled uptake clinical trial aims to evaluate the system's efficacy and safety for renal denervation in patients with uncontrolled hypertension and chronic kidney disease, 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
Shanghai Golden Leaf MedTec Co. Ltd
Beijing Anzhen Hospital
Shanghai Zhongshan Hospital
Guangdong Provincial People's Hospital
The Second Affiliated Hospital of Harbin Medical University
West China Hospital
Jiangxi Provincial People's Hopital
Navy General Hospital, Beijing
Qilu Hospital of Shandong University
Xijing Hospital
Fujian Provincial Hospital
First Affiliated Hospital of Fujian Medical University
Henan Provincial People's Hospital
Hebei Provincial People's Hospital
Anhui Provincial Hospital
The First Hospital of Jilin University
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital of Guangxi Medical University
Qianfoshan Hospital
Ningbo Medical Center Lihuili Hospital
Mianyang Central Hospital
The Third People's Hospital of Chengdu
General Hospital of the Eastern Theater Command
China-Japan Union Hospital, Jilin University
Shanxi Bethune Hospital
Second Hospital of Shanxi Medical University
Yan'an Affiliated Hospital of Kunming Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The trial will enroll 236 subjects (trial group: control group = 1:1)
Intervention model description
Prospective, Multicenter, Randomized, Parallel-Controlled,The trial will enroll 236 subjects (trial group: control group = 1:1).
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, at the time of consent; 2. Hypertensive subjects who have been taking 2 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure still ≥150 mmHg and \<180 mmHg, and 24-hour ambulatory mean systolic blood pressure (24h SBP) ≥135 mmHg and \<170 mmHg; or who have been taking ≥3 types of standardized antihypertensive drugs continuously and stably for at least 4 weeks, with office systolic blood pressure ≥140 mmHg and \<180 mmHg, and 24h SBP ≥130 mmHg and \<170 mmHg; 3. Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73m² and \<60 mL/min/1.73m²; 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. 4. Prior renal artery intervention or prior renal denervation. 5. 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.). 6. Allergic to contrast agents. 7. 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. 8. Orthostatic hypotension. 9. Type 1 diabetes mellitus. 10. Primary pulmonary arterial hypertension. 11. History of bleeding diathesis and haematological disorders or coagulopathy 12. History of thromboembolic event within 6 months. 13. History of stroke or transient ischemic attack (TIA) within 6 months. 14. Severe peripheral arterial disease or unstable abdominal aortic aneurysm. 15. Severe valvular heart disease or anticipated need for surgical valve replacement during the study period. 16. NYHA Class III/IV heart failure at screening or hospitalization for exacerbation of chronic heart failure within the past six months. 17. History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker. 18. Acute kidney injury (AKI) within 4 weeks before enrollment or acute kidney disease ，AKI: ≥50% increase in serum creatinine within 7 days, or absolute increase ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours, or oliguria (\<0.5 mL·kg-¹·h-¹ for ≥6 hours). 19. Severe hepatic dysfunction. 20. Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS. 21. Known drug or alcohol dependence, difficulty understanding the study protocol, inability or unwillingness to comply with follow-up requirements. 22. Current or planned participation in other clinical trials of drugs or medical devices (post-marketing registry studies permitted). 23. Acute or severe systemic infection. 24. Other conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 24-hour Ambulatory Systolic Blood Pressure at Month 6 (ABPM) | Baseline to Month 6 post-procedure | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; change is Month 6 minus Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in 24-hour Ambulatory Diastolic Blood Pressure at Month 6 (ABPM) | Baseline to Month 6 post-procedure | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; |
| Change from Baseline in 24-hour Ambulatory Blood Pressure (including both systolic and diastolic BP) | Baseline to Months 1, 3, 12, 24, and 36 post-procedure | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; |
| Change from Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure (ABPM) | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; |
| Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP) | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure | measured by validated office blood pressure monitoring |
| Percentage of Participants with 24-hour Ambulatory Systolic BP <130 mmHg | Months 1, 3, 6, 12, 24, and 36 post-procedure | 24-hour mean systolic BP measured by validated ambulatory BP monitoring; |
| Percentage of subjects with office systolic BP within the target ranges (<140 mmHg and <130 mmHg) | Months 1, 3, 6, 12, 24, and 36 post-procedure | measured by validated office blood pressure monitoring |
| Responder Rate: ≥5 mmHg Reduction in 24-hour Ambulatory Systolic BP | Months 1, 3, 6, 12, 24, and 36 post-procedure | Proportion of participants with a reduction ≥5 mmHg from baseline in 24-hour mean systolic BP by ABPM. |
| Change from Baseline in Antihypertensive Medication Use | Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 1, 3, 6, 12, 24, and 36 post-procedure | Change in the number of concurrently prescribed antihypertensive agents . |
| Change from Baseline in Cardiac Function (by Echocardiography) | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure | by Echocardiography |
| Change from Baseline in Heart Rate (by ECG) | Baseline to Months 1, 3, 6, 12, 24, and 36 post-procedure | Resting heart rate measured by standard 12-lead ECG; change is Follow-up minus Baseline. |
| Device and Procedure Success | Intra-procedure (Day 0) | Successful completion of intended renal denervation ablations in eligible segments of the renal arteries without device malfunction requiring replacement or procedure abortion. |
| Periprocedural major adverse event (MAE) rate | Baseline to 30 days post-procedure | Hospitalization for a clinically significant hypotensive or hypertensive event; Vascular complications requiring surgical repair, endovascular therapy, thrombin injection, or blood transfusion; Renal artery dissection or perforation requiring intervention; Significant embolic events causing end-organ damage or requiring intervention to prevent it; Severe renal impairment (\>50% decrease in eGFR or \>50% increase in serum creatinine from baseline) or ESRD (eGFR \<15 mL/min/1.73 m²); All-cause death; New renal artery stenosis ≥70% (confirmed by angiography). |
| Safety event rates | Baseline to Months 36 post-procedure | Interventional complications: pseudoaneurysm, thrombosis, dissection, AV fistula, rupture or perforation, renal artery stenosis. All-cause mortality. MACCE: stroke (ischemic or hemorrhagic), ACS (AMI or unstable angina), cardiovascular death. Severe renal dysfunction (eGFR decrease \>50% or creatinine increase \>50% from baseline) or ESRD (eGFR \<15 mL/min/1.73 m²). New renal artery stenosis ≥70% within 6 months (confirmed by angiography). |
Countries
China
Outcome results
None listed