Laparoscopic Adventitial Renal Denervation (RDN) for Refractory Hypertension

NCT07108829 | Not Yet Recruiting

• 1 other identifier: HenanlCE202503
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Hypertension or Drug-intolerant Hypertension

Keywords

Hypertension; Resistant Hypertension; Renal Denervation; Laparoscopic; Radiofrequency Ablation; Sympathetic Nerves

Outcome Measures

Primary Outcomes (2)

• 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.

  180 days post-procedure

• 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.

  180 days post-procedure

Secondary Outcomes (4)

• Procedural Success Rate

  Intra-procedural

• Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure at 180 Days

  Baseline and 180 days post-procedure

• Incidence of Major Adverse Events (MAE)

  Up to 180 days post-procedure

• Incidence of Laparoscopic Surgery-Related Adverse Events

  Up to 30 days post-procedure

Study Arms (1)

Laparoscopic Adventitial RDN

EXPERIMENTAL

Participants will undergo a 28-day run-in period on a standardized antihypertensive medication regimen. Following this period, all participants will receive the investigational treatment, which is a laparoscopic renal artery adventitial denervation procedure. Participants will be followed for 180 days post-procedure

Device: Renal Artery Radiofrequency Ablation Clamp

Interventions

Renal Artery Radiofrequency Ablation Clamp DEVICE

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.

Laparoscopic Adventitial RDN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead
• Hunan Ept Medical Co., Ltd.: collaborator
• Shanghai Hongtong Industrial Co., Ltd.: collaborator

Study Sites (1)

Fuwai Huazhong Cardiovascular Hospital

Zhengzhou, Henan, China

Location

Related Publications (5)

• Gao C, Zhao L, Zhu L, Li M, Ding D, Liu Z, Fan Z, Zhang Y, Zhao W, Wang J. Laparoscopic-based perivascular unilateral renal sympathetic nerve denervation for treating resistant hypertension: a case report. Hypertens Res. 2019 Aug;42(8):1162-1165. doi: 10.1038/s41440-019-0237-3. Epub 2019 Feb 27.

  PMID: 30814662 BACKGROUND

• Baik J, Song WH, Yim D, Lee S, Yang S, Lee HY, Choi EK, Jeong CW, Park SM. Laparoscopic Renal Denervation System for Treating Resistant Hypertension: Overcoming Limitations of Catheter-Based Approaches. IEEE Trans Biomed Eng. 2020 Dec;67(12):3425-3437. doi: 10.1109/TBME.2020.2987531. Epub 2020 Nov 19.

  PMID: 32310758 BACKGROUND

• Liu Y, Zhu B, Zhu L, Zhao L, Ding D, Liu Z, Fan Z, Zhao Q, Zhang Y, Wang J, Gao C. Clinical outcomes of laparoscopic-based renal denervation plus adrenalectomy vs adrenalectomy alone for treating resistant hypertension caused by unilateral aldosterone-producing adenoma. J Clin Hypertens (Greenwich). 2020 Sep;22(9):1606-1615. doi: 10.1111/jch.13963. Epub 2020 Aug 18.

  PMID: 32812324 BACKGROUND

• Zhao L, Su E, Yang X, Zhu B, Fan Z, Wang X, Qi D, Zhu L, Bai M, Zhang Y, Zhao Q, Li M, Gao C. Laparoscopic-based perivascular renal sympathetic nerve denervation: a feasibility study in a porcine model. Eur J Med Res. 2020 Jun 18;25(1):22. doi: 10.1186/s40001-020-00422-5.

  PMID: 32552871 BACKGROUND

• Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, Abraham WT, Esler M. Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet. 2009 Apr 11;373(9671):1275-81. doi: 10.1016/S0140-6736(09)60566-3. Epub 2009 Mar 28.

  PMID: 19332353 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Chuanyu Gao, MD, Phd

CONTACT

13937165590; gaocy6208@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)