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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Six-channel RF Renal Denervation System
DeviceDSA-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)
Parallel controln with sham operation(there is no rade and/or generic name,It is a blank control sham operation)
Procedure/SurgerySham 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Renal denervationExperimental treatment 1 intervention
Group B: Parallel control with sham operationSham comparator 1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
Change from Baseline in Daytime and Nighttime Ambulatory Systolic /diastolic Blood Pressure (ABPM)
24-hour mean systolic /diastolic BP measured by validated ambulatory BP monitoring;
Time frame
Baseline to 3 Months2
Percentage of Participants with 24-hour Ambulatory BP <130 /80 mmHg
24-hour mean BP measured by validated ambulatory BP monitoring;
Time frame
Months 3 post-procedure3
Change from Baseline in Office Blood Pressure (including both systolic and diastolic BP)
measured by validated office blood pressure monitoring
Time frame
Baseline to Months 3 post-procedure4
Change from Baseline in Antihypertensive Medication Use
Change in the number of concurrently prescribed antihypertensive agents
Time frame
Baseline to hospital discharge or Day 7 (whichever occurs first), and to Months 3 post-procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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