Overview
This is a prospective, multicenter, randomized controlled study designed to evaluate the effect of renal denervation (RDN) ablation duration on blood pressure reduction in patients with hypertension.
A total of 220 eligible patients with hypertension will be randomly assigned in a 1:1 ratio to one of two treatment groups. All participants will undergo renal denervation using a radiofrequency ablation system and a single-use multielectrode renal denervation catheter. In Group 1, each ablation site in the main renal arteries and their branches will be treated for 1 minute. In Group 2, each ablation site in the main renal arteries will be treated for 2 minutes, while each site in the renal artery branches will be treated for 1 minute.
The study aims to determine whether a longer ablation duration in the main renal arteries provides greater blood pressure reduction and clinical benefit. Participants will be followed up at 1, 3, 6, and 12 months after the procedure to assess blood pressure and clinical outcomes.
Description
Study Background and Rationale
Renal denervation (RDN) is an interventional treatment for hypertension that targets renal sympathetic nerves using catheter-based ablation. The duration of radiofrequency ablation may influence the treatment effect. However, whether extending the ablation duration in the main renal arteries results in greater blood pressure reduction remains to be determined.
This prospective, multicenter, randomized controlled study is designed to compare two RDN ablation strategies with different ablation durations in the main renal arteries, while maintaining the same ablation duration at each site in the renal artery branches.
Study Design and Population
A total of 220 eligible patients with hypertension will be enrolled and randomly assigned in a 1:1 ratio to Group 1 or Group 2.
Eligible participants will have a clinic systolic blood pressure of at least 150 mmHg but less than 180 mmHg and/or a diastolic blood pressure of at least 90 mmHg, together with a 24-hour mean systolic blood pressure of at least 140 mmHg but less than 170 mmHg. Participants will be receiving 1 to 3 standard antihypertensive medications, or will be unable to tolerate such medications because of contraindications or adverse drug reactions, according to the study eligibility criteria.
Study Interventions
All participants will undergo renal denervation under digital subtraction angiography (DSA) guidance using a radiofrequency ablation system and a single-use multielectrode renal denervation catheter.
Group 1: Each ablation site in the main renal arteries and their branches will receive radiofrequency ablation for 1 minute.
Group 2: Each ablation site in the main renal arteries will receive radiofrequency ablation for 2 minutes, while each ablation site in the renal artery branches will receive radiofrequency ablation for 1 minute.
The two groups will be compared to evaluate the effect of the different ablation durations on blood pressure reduction.
Follow-up and Outcome Assessment
All participants will be followed up at 1, 3, 6, and 12 months after the RDN procedure. Blood pressure and other prespecified clinical outcomes will be assessed according to the study protocol.
Study Objective
The primary objective is to determine whether extending the ablation duration at each site in the main renal arteries from 1 minute to 2 minutes provides greater blood pressure reduction. The findings are expected to provide clinical evidence to support the standardization and optimization of RDN procedural protocols.
Eligibility
Inclusion Criteria:
- Men or women aged 20 to 80 years, inclusive.
- A history of hypertension for at least 3 months.
- Clinic systolic blood pressure ≥150 mmHg and \<180 mmHg, and/or clinic diastolic blood pressure ≥90 mmHg, together with a 24-hour mean systolic blood pressure ≥140 mmHg and \<170 mmHg, as specified in the study protocol.
- Patients receiving 1 to 3 standard antihypertensive medications at baseline, or patients who cannot tolerate antihypertensive medications because of contraindications or adverse drug reactions.
- The participant or legally authorized representative is able to understand the study, and the participant voluntarily signs the written informed consent form.
Exclusion Criteria:
- Pregnancy.
- Unilateral or bilateral renal artery anatomical abnormalities unsuitable for renal denervation, including renal artery stenosis \>50%, renal artery aneurysm, renal artery dysplasia, or renal artery diameter \<3 mm or \>8 mm. Four radiofrequency ablations in the main renal artery or an accessory renal artery are not permitted.
- A solitary kidney, a history of kidney transplantation, or an estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m².
- Secondary hypertension, including hypertension caused by primary aldosteronism, pheochromocytoma/paraganglioma, Cushing syndrome, hyperthyroidism, aortic coarctation, or renovascular disease.
- Allergy to contrast media.
- Major surgery or traumatic injury within 1 month before enrollment; acute coronary syndrome within 6 months before enrollment; or planned surgery or cardiovascular intervention within the next 6 months.
- Orthostatic hypotension.
- Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c \>8%.
- Significant bleeding tendency or hematologic disorders, including a platelet count \<50 × 10⁹/L or an international normalized ratio (INR) \>1.5.
- A history of deep vein thrombosis within 6 months.
- Stroke or transient ischemic attack (TIA) within 3 months.
- Severe peripheral vascular disease or an abdominal aortic aneurysm requiring surgical intervention.
- Severe valvular heart disease or a condition likely to require surgical valve replacement during the study period.
- A history of atrial fibrillation or multifocal atrial tachycardia within 6 months, or a history of pacemaker or implantable cardioverter-defibrillator (ICD) implantation.
- A serious comorbid condition that may affect study participation or survival, such as malignancy or AIDS.
- Acute or severe systemic infection.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.
