Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study

NCT07664787 | Not Yet Recruiting DMC

• 1 other identifier: Ruijin2026-293
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension; Grade 1

Keywords

hypertension; renal denervation; grade I

Outcome Measures

Primary Outcomes (1)

• Change in 24-h ambulatory BP at 3 months post-procedure compared between the 2 groups.

  the change in 24-h ambulatory systolic/diastolic BP at 3 months post-procedure compared between the 2 groups.

  3 months

Secondary Outcomes (5)

• Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)

  Baseline to 3 Months

• Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg

  Months 3 post-procedure

• Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)

  Baseline to Months 3 post-procedure

• Change from Baseline in Antihypertensive Medication Use

  Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedure

• change from baseline in the time in target range of 24 hour ambulatory blood pressure

  Months 3 post-procedure

Study Arms (2)

Renal denervation

EXPERIMENTAL

Participants receive percutaneous renal sympathetic denervation under digital subtraction angiography (DSA) guidance using a six-channel radiofrequency generator(model 25D1G, software release SRG-V1) and ultra-guiding radiofrequency denervation catheter (model 25C6W127F115T) manufactured by Shanghai Golden Leaf MedTec Co., Ltd(BRATTEA). All participants receive a standardized antihypertensive regimen for ≥4 weeks before the procedure and thereafter per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3 months.

Device: Six-channel RF Renal Denervation System

Parallel control with sham operation

SHAM COMPARATOR

Participants undergo a sham procedure: femoral artery puncture and selective renal angiography under DSA guidance are performed. The RF generator is connected to a dummy load, and activation sounds are emitted, but no energy is delivered. Participants remain on the procedure table for at least 35 minutes before sheath removal. Background standardized antihypertensive therapy is provided for ≥4 weeks pre-procedure and continued per protocol. Follow-up visits occur at 7 days or before discharge, and at 1 and 3months.

Procedure: Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)

Interventions

Six-channel RF Renal Denervation System DEVICE

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)

Renal denervation

Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation) PROCEDURE

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.

Parallel control with sham operation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 65 years inclusive
• Hypertension duration longer than 3 months
• 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;
• 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.

You may not qualify if:

• Pregnant or breastfeeding, or planning pregnancy during the study.
• 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).
• Subjects with a solitary kidney, prior renal transplantation, or requiring dialysis or eGFR\<40mL/min/1.73m2。
• 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.).
• Allergic to contrast agents.
• 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.
• Orthostatic hypotension.
• Type 1 diabetes mellitus.
• History of bleeding diathesis and haematological disorders or coagulopathy
• History of thromboembolic event within 6 months.
• History of stroke or transient ischemic attack (TIA) within 6 months.
• Severe peripheral arterial disease or unstable abdominal aortic aneurysm.
• 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.
• History of ventricular fibrillation, polymorphic ventricular tachycardia within six months, or prior implantation of an implantable cardioverter-defibrillator (ICD) or pacemaker.
• Concomitant severe diseases that may interfere with study participation or affect survival, such as malignancy or AIDS.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Guangdong Provincial People's Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shandong First Medical University: collaborator
• Shanghai Institute of Hypertension: collaborator
• Shanghai Golden Leaf MedTec Co. Ltd: collaborator

MeSH Terms

Conditions

Hypertension; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jian-Zhong Xu, M.D. Ph.D

CONTACT

+86 21 64370045; jianzhongxv@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief of department of Hypertension

Study Record Dates

• First Submitted: May 25, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share