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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Hypertension, Grade 1

In brief

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.

Key facts

Study ID

NCT07664787

Run by

Ruijin Hospital

People needed

20

Starts

2026-07-01

Expected to finish

2027-12-30

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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.
• Acute or severe systemic infection.
• Other conditions deemed unsuitable for participation by the investigator.

Full record on ClinicalTrials.gov

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