Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHenan Institute of Cardiovascular Epidemiology
About this trial
This is a first-in-human study to test the safety and effectiveness of a new device-based treatment for high blood pressure that is difficult to control with medicine. This condition is known as refractory hypertension.
The study will enroll 10 adults aged 18 to 65 whose high blood pressure is not controlled even though they are taking three or more blood pressure medications.
The treatment involves a new medical device called a Renal Artery Radiofrequency Ablation Clamp. This device is used during a keyhole (laparoscopic) surgery. It works by applying controlled heat (radiofrequency energy) to the outside of the arteries that supply blood to the kidneys. This procedure, known as renal denervation, aims to calm the nerves around these arteries that contribute to high blood pressure.
Participants who join the study will first be monitored on a standard set of blood pressure medicines to confirm they are eligible. If they qualify, they will undergo the keyhole surgery. After the procedure, participants will be followed for 180 days (about 6 months) and will have several follow-up visits to check their blood pressure and overall health.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
Renal Artery Radiofrequency Ablation Clamp
DeviceThis device is a clamp used during a laparoscopic surgical procedure. It is placed on the external surface (adventitia) of the renal artery and is connected to a radiofrequency generator. It delivers targeted radiofrequency energy to ablate the renal sympathetic nerves.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Laparoscopic Adventitial RDNExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of Achieving Target Office Systolic Blood Pressure at 180 Days
The percentage of subjects whose office systolic blood pressure (SBP) is less than 140mmHg at the 180-day post-procedure follow-up. Office blood pressure will be measured in a resting state according to a standardized procedure.
Time frame
180 days post-procedure2
Change From Baseline in Antihypertensive Medication Composite Score at 180 Days
The change from baseline in a composite score reflecting the type and dose of antihypertensive medication required to achieve a target office SBP of \<140mmHg. The score is calculated as (number of drug classes) multiplied by (the sum of the doses), where a standard daily dose is defined as 1, a half dose is 0.5, and a double dose is 2. The change is calculated as the baseline score minus the 180-day score.
Time frame
180 days post-procedureSecondary outcomes
1
Procedural Success Rate
The percentage of procedures where the renal artery radiofrequency ablation clamp is successfully positioned and the denervation procedure is completed without related complications, which include renal artery perforation and renal artery embolism.
Time frame
Intra-procedural2
Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure at 180 Days
The reduction in mean 24-hour ambulatory systolic blood pressure (SBP) at 180 days post-procedure compared to the baseline measurement.
Time frame
Baseline and 180 days post-procedure3
Incidence of Major Adverse Events (MAE)
The percentage of subjects experiencing one or more Major Adverse Events. MAEs include all-cause mortality, new myocardial infarction, major bleeding, end-stage renal disease, major embolic events causing end-organ damage, renal artery re-intervention, renal artery perforation or dissection, vascular complications requiring intervention, hospitalization for hypertensive crisis, new stroke, or new-onset renal artery stenosis (≥70%).
Time frame
Up to 180 days post-procedure4
Incidence of Laparoscopic Surgery-Related Adverse Events
The percentage of subjects experiencing adverse events related to the laparoscopic procedure. These include pneumoperitoneum-related complications (e.g., gas embolism, pneumothorax), injury to major abdominal or retroperitoneal vessels, visceral injury (bowel, bladder, liver, spleen), or ureteral injury.
Time frame
Up to 30 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henan Institute of Cardiovascular Epidemiology
Lead sponsor
Hunan Ept Medical Co., Ltd.
Collaborator
Shanghai Hongtong Industrial Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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