Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension

NCT07108829 · tracked via the Priya Life Science China tracker

Sponsor

Henan Institute of Cardiovascular Epidemiology

Phase

Not applicable

Started

2025-08

Last updated

2025-08-07

Condition(s) studied

Refractory Hypertension or Drug-intolerant Hypertension

Investigational drug(s) / intervention(s)

Renal Artery Radiofrequency Ablation Clamp

Renal Artery Radiofrequency Ablation Clamp: This 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.

Study summary

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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Inclusion Criteria: Age ≥18 years and ≤65 years, any sex. Diagnosed with primary hypertension. History of hypertension for at least 6 months. Blood pressure meets the following two conditions: Office systolic blood pressure ≥140mmHg and ≤180mmHg, and office diastolic blood pressure ≥90mmHg. If not taking a beta-blocker, resting heart rate must be ≥70bpm. 24-hour ambulatory blood pressure measurement shows an average systolic pressure ≥130mmHg or a daytime average systolic pressure ≥135mmHg. Has a history of antihypertensive medication use within the last 6 months with uncontrolled blood pressure. Before enrollment, must undergo at least 28 days of a standardized medication regimen (including a diuretic and at least three drugs in total) with ≥80% compliance, while office SBP remains ≥140mmHg and ≤180mmHg, and office DBP remains ≥90mmHg. Patient is willing and able to comply with follow-up requirements and has signed the informed consent form. Exclusion Criteria: Secondary hypertension. Target renal artery anatomy is unsuitable, including: Renal artery diameter \>9mm or \<4mm. Multiple renal arteries. Severe calcification, stenosis \>50%, malformation, fibromuscular dysplasia, or aneurysm in either renal artery. History of renal artery intervention (e.g., balloon angioplasty or stenting). Unsuitable for laparoscopic surgery via the retroperitoneal approach, including prior retroperitoneal surgery, retroperitoneal fibrosis, or severe obesity (BMI \> 40 kg/m²). History of kidney transplant or severe renal impairment (eGFR \< 45 mL/min/1.73m²). Hospitalization for a hypertensive crisis within the past year. Severe liver dysfunction (ALT or AST \> 3 times the upper limit of normal). Type 1 diabetes. History of a cardiovascular event (e.g., myocardial infarction, unstable angina) or cerebrovascular event (e.g., stroke, TIA) within the last 6 months. Pregnancy or planning to become pregnant during the trial. Participation in any other investigational drug or device trial within 3 months prior to screening.

Primary outcome measure(s)

Rate of Achieving Target Office Systolic Blood Pressure at 180 Days — 180 days post-procedure
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.
Change From Baseline in Antihypertensive Medication Composite Score at 180 Days — 180 days post-procedure
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.

Trial sites (1)

Facility	City	Region	Status
Fuwai Huazhong Cardiovascular Hospital	Zhengzhou	Henan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07108829 on ClinicalTrials.gov ↗ ← All trials in China