Using 3D mapping to guide renal denervation for hypertension treatment

3D Cardiac Electrophysiological Mapping System on Renal Artery Radiofrequency Ablation System for Hypertension: a Prospective, Multicenter, Randomized Controlled Trial

This study is testing a new way to treat high blood pressure using a special mapping system to guide a procedure that targets the kidneys, and it's for people with essential hypertension.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Shanghai Hongdian Medical CO., LTD (Industry-sponsored)
• Locations: 27 sites (Chongqing, Chongqing Municipality and 26 other locations)
• Trial ID: NCT05590871 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of a renal artery radiofrequency ablation system, guided by a three-dimensional cardiac electrophysiological mapping system, for treating essential hypertension. It is a prospective, multi-center, randomized controlled study that includes both drug-control and sham-control research components. Participants will be monitored for blood pressure and medication compliance over a 12-month period following the procedure. The study involves a total of 245 subjects, with random assignments to different treatment groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with essential hypertension that is not controlled by standard medication.

Not a fit: Patients with renal artery anatomy failures or those not willing to undergo surgical treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new, effective treatment option for patients with resistant hypertension.

How similar studies have performed: Previous studies have shown promise in renal denervation techniques, but this specific approach using 3D mapping is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Males or females aged ≥18 and ≤70 (not pregnant, breastfeeding, and have no reproductive plan within one year);
* Patients with essential hypertension, antihypertensive drug intolerance, and willing to undergo surgical treatment;
* Ambulatory blood pressure measurement 24-hour average systolic blood pressure ≥130mmHg or daytime ≥135mmHg, and pulse pressure difference \<80 mmHg;
* A history of using antihypertensive medication within six months and blood pressure is still uncontrollable; standardized medication (at least two drugs) for at least 28 days before enrollment, and medication compliance ≥ 80%, office systolic blood pressure (OSBP) ) ≥ 150 mmHg and \<180 mmHg, diastolic blood pressure (DBP) ≥ 90 mmHg;
* The patients agree to participate in this clinical trial and sign the informed consent form, agreeing to follow-up evaluation under the requirements of the verification protocol.

Exclusion Criteria:

* Renal artery anatomy failures include:

  1. Renal artery diameter \<4mm or treatment length \<20mm;
  2. Renal artery stenosis \>50% or renal aneurysm on either side;
  3. A history of renal artery intervention, including balloon angioplasty or stenting or RDN;
* Glomerular filtration rate (eGFR) \<45mL/min/1.73m2 (MDRD formula);
* History of hospitalization for hypertensive crisis in the past year;
* During the screening and lead-in period, the patient used antihypertensive drugs other than the standard antihypertensive drugs prescribed in this study protocol;
* Nocturnal sleep apnea syndrome requires mechanical ventilation (such as tracheostomy);
* Those who have or are currently suffering from the following diseases or conditions:

  1. Primary pulmonary hypertension (moderate to severe);
  2. Type I diabetes;
  3. History of any cerebrovascular events (eg, stroke, transient cerebral ischemic event, cerebrovascular accident) within 3 months;
  4. History of any serious cardiovascular event within 3 months (eg, myocardial infarction, CABG, acute heart failure requiring hospitalization (NYHA III-IV), unstable angina attack);
  5. Factors that interfere with blood pressure measurement in any case (eg, patients with severe peripheral vascular disease, abdominal aortic aneurysm, bleeding disorders such as thrombocytopenia, hemophilia, severe anemia);
  6. Arranged or planned surgery or cardiovascular intervention within the next 6 months;
  7. Patients with malignant tumors and end-stage diseases who survival period is less than 1year;
* Patients with secondary hypertension.
* Patients who are deemed inappropriate to participate in this trial by other investigators.

Where this trial is running

Chongqing, Chongqing Municipality and 26 other locations

• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
• Chongqing General Hospital — Chongqing, Chongqing Municipality, China (Recruiting)
• Cardiovascular Hospital Affiliated to Xiamen University — Xiamen, Fujian, China (Recruiting)
• The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (Recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Recruiting)
• First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• The 7th People's Hospital of Zhengzhou — Zhengzhou, Henan, China (Recruiting)
• Zhengzhou Central Hospital — Zhenzhou, Henan, China (Recruiting)
• Changzhou No.2 People's Hospital — Changzhou, Jiangsu, China (Recruiting)
• Ansteel Group General Hospital — Anshan, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Not_yet_recruiting)
• The First Hospital of China Medical University — Shengyang, Liaoning, China (Recruiting)
• The People's Hospital of Liaoning Province — Shenyang, Liaoning, China (Recruiting)
• Weifang People's Hospital — Weifang, Shandong, China (Recruiting)
• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• The Second Affiliated Hospital of Air Force Medical University of PLA — Xi’an, Shanxi, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• First Affiliated Hospital of Chengdu Medical College — Chengdu, Sichuan, China (Recruiting)
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China (Recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Recruiting)
• Tianjin Chest Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Tianjin First Central Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• Yan'an Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Recruiting)
• Shenzhen Guangming District People's Hospital — Shenzhen, China (Recruiting)

Study contacts

• Study coordinator: Yuehui Yin, MD

Conditions Hypertension