HypertensionRDN-DANCT07876479
The Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy
A study testing Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016) in people with Hypertension and Resistant Hypertension, run by Ruijin Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypertension, Resistant Hypertension
- What is being tested?
- Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2026to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Jianzhong Xu, 86 21 64370045, jianzhongxv@outlook.com
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study on the Effect of Ablation Duration of Renal Denervation on Antihypertensive Efficacy
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.
Read the detailed 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.
- Conditions
- Hypertension, Resistant Hypertension
- Being tested
- Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)
- Keywords
- hypertension, renal denervation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016)Procedure or surgery
Catheter-based renal denervation (RDN) will be performed under digital subtraction angiography (DSA) guidance using the same Medtronic RDN016 single-use multielectrode renal artery radiofrequency ablation catheter in both study groups. Participants will be randomized in a 1:1 ratio to two ablation-duration strategies. 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 ablation site in the renal artery branches will be treated for 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Standard-Duration RDN | Experimental | Participants will undergo renal denervation (RDN) and radiofrequency ablation will be performed for 1 minute at each ablation site in both the main renal arteries and their branches. Receives: Procedure: Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016) |
| Group 2: Extended-Duration RDN | Experimental | Participants will undergo renal denervation (RDN) and radiofrequency ablation will be performed for 2 minutes at each ablation site in the main renal arteries and for 1 minute at each ablation site in the renal artery branches. Receives: Procedure: Renal Denervation Using a Multielectrode Radiofrequency Ablation Catheter (RDN016) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-Hour Mean Systolic Blood Pressure From Baseline to 6 Months
The change in 24-hour mean systolic blood pressure from baseline to 6 months after renal denervation (RDN).
Measured: 6 months
Secondary outcomes (6)
Change in Mean Daytime Systolic Blood Pressure From Baseline to 6 Months
The change in mean daytime systolic blood pressure from baseline to 6 months after renal denervation (RDN), measured by 24-hour ambulatory blood pressure monitoring. Daytime is defined as 6:00 AM to 10:00 PM.
Measured: 6 months
Change in Mean Nighttime Systolic Blood Pressure From Baseline to 6 Months
The change in mean nighttime systolic blood pressure from baseline to 6 months after RDN, measured by 24-hour ambulatory blood pressure monitoring. Nighttime blood pressure will be assessed according to the nighttime period defined in the study protocol.
Measured: 6 months
Change in Office Systolic Blood Pressure From Baseline to 6 Months
The change in office systolic blood pressure from baseline to 6 months after RDN. Office blood pressure will be measured according to the study protocol.
Measured: 6 months
Change in Office Diastolic Blood Pressure From Baseline to 6 Months
The change in office diastolic blood pressure from baseline to 6 months after RDN. Office blood pressure will be measured according to the study protocol.
Measured: 6 months
Change in Antihypertensive Medication Burden From Baseline to 6 Months
The change in antihypertensive medication burden from baseline to 6 months after RDN. All antihypertensive medications will be recorded, including drug names, daily doses, dosing frequencies, and dose adjustments. Medication burden will be calculated as the sum of the ratios of the actual daily dose to the recommended maximum daily dose for each medication, based on the JNC 7 guidelines.
Measured: 6 months
Change in Number and Dosage of Antihypertensive Medications From Baseline to 6 Months
The change in the number and dosage of antihypertensive medications from baseline to 6 months after RDN. The number of antihypertensive medications and the daily dose of each medication will be recorded and compared between baseline and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start9 Jul 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China-Japan Union Hospital, Jilin University, The First Affiliated Hospital of Dalian Medical University, Guangdong Provincial People's Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Xu jianzhong, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876479
- Sponsor's protocol ID
- Ruijin2026-571
- Acronym
- RDN-DA
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No