Safety and Efficacy of Renal Denervation for Untreated Grade I Hypertension: a Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.).
Trial design
Treatments tested in this trial
- Six-channel RF Renal Denervation System
- Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)
Treatment groups
20 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Ruijin Hospital
Lead sponsor
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
Source ClinicalTrials.gov