Longer or shorter ablation duration in renal denervation to lower blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized trial comparing two renal denervation ablation strategies. All participants have hypertension and will receive a radiofrequency renal denervation procedure with a standardized catheter. Group 1 treats main renal arteries and branches for 1 minute per site; Group 2 treats main renal arteries for 2 minutes and branches for 1 minute. Participants will be followed for 12 months with periodic blood pressure assessments to determine the impact of ablation duration on antihypertensive effect.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men or women aged 20 to 80 years, inclusive.
2. A history of hypertension for at least 3 months.
3. 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.
4. Patients receiving 1 to 3 standard antihypertensive medications at baseline, or patients who cannot tolerate antihypertensive medications because of contraindications or adverse drug reactions.
5. The participant or legally authorized representative is able to understand the study, and the participant voluntarily signs the written informed consent form.

Exclusion Criteria:

1. Pregnancy.
2. 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.
3. A solitary kidney, a history of kidney transplantation, or an estimated glomerular filtration rate (eGFR) \<40 mL/min/1.73 m².
4. Secondary hypertension, including hypertension caused by primary aldosteronism, pheochromocytoma/paraganglioma, Cushing syndrome, hyperthyroidism, aortic coarctation, or renovascular disease.
5. Allergy to contrast media.
6. 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.
7. Orthostatic hypotension.
8. Type 1 diabetes mellitus or type 2 diabetes mellitus with HbA1c \>8%.
9. Significant bleeding tendency or hematologic disorders, including a platelet count \<50 × 10⁹/L or an international normalized ratio (INR) \>1.5.
10. A history of deep vein thrombosis within 6 months.
11. Stroke or transient ischemic attack (TIA) within 3 months.
12. Severe peripheral vascular disease or an abdominal aortic aneurysm requiring surgical intervention.
13. Severe valvular heart disease or a condition likely to require surgical valve replacement during the study period.
14. A history of atrial fibrillation or multifocal atrial tachycardia within 6 months, or a history of pacemaker or implantable cardioverter-defibrillator (ICD) implantation.
15. A serious comorbid condition that may affect study participation or survival, such as malignancy or AIDS.
16. Acute or severe systemic infection.
17. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.

Where it's running

• Ruijin hospital, Shanghai Jiao Tong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Jian-Zhong Xu, M.D. Ph.D
• Email: jianzhongxv@outlook.com
• Phone: 86 21 64370045

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.