HypertensionNCT06783296
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
A study testing Renal Denervation and Renal Angiography in people with Hypertension and Renal Denervation Therapy, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Renal Denervation Therapy
- What is being tested?
- Renal Denervation and Renal Angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, with no restriction on sex or ethnicity;
- Diagnosis of primary hypertension, with no prior use of antihypertensive medication, and in the untreated state presenting with office systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) ≥90 mmHg, as well as 24-hour ambulatory blood pressure monitoring (ABPM) showing SBP <130 mmHg and DBP ≥80 mmHg;
- Willingness to participate and provision of written informed consent.
Who cannot join
- DBP ≥110 mmHg;
- Secondary hypertension;
- Requirement for antihypertensive or blood pressure-lowering medications due to comorbid conditions (e.g., SGLT2 inhibitors, GLP-1 receptor agonists);
- Cardiac arrhythmias interfering with blood pressure measurement (e.g., atrial fibrillation);
- Contraindications to RDN, including renal transplantation, renal insufficiency (eGFR <45 mL/min/1.73 m²), renal artery anatomy unsuitable for the procedure (inability to access the renal vasculature; renal artery diameter <4 mm or length <20 mm; hemodynamically or anatomically significant renal artery abnormalities or stenosis; prior coronary or renal artery interventions including angioplasty or stenting), and severe hepatic impairment;
- Contraindications to interventional procedures such as coagulopathy;
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- Pregnancy, planning pregnancy, or breastfeeding;
- Life expectancy <1 year;
- Participation in another clinical trial.
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
Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Yi Zhang, +86 18917686332, yizshcn@gmail.com
About this study
Official title: Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial
This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes in mean 24-hour ambulatory diastolic blood pressure over a 6-month follow-up period. The study is expected to provide evidence for the use of RDN as a treatment for IDH.
- Conditions
- Hypertension, Renal Denervation Therapy
- Being tested
- Renal Denervation, Renal Angiography
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal DenervationProcedure or surgery
Renal denervation (RDN) was performed using radiofrequency ablation in the cardiac catheterization laboratory equipped with a digital subtraction angiography (DSA) system. Under intravenous anesthesia, femoral artery access was obtained and a renal denervation sheath was advanced. An ablation catheter was then introduced to both renal arteries, and ablations were applied across four quadrants to achieve circumferential denervation. Throughout the procedure, vital signs were continuously monitored, and vasodilators or anticholinergics (e.g., nitroglycerin, atropine) were prepared to prevent vascular spasm or related complications. After completion, the femoral access site was closed and compressed, and patients were returned to the ward following stabilization of vital signs.
Renal AngiographyProcedure or surgery
Renal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN.
| Study group | Role | What they receive |
|---|---|---|
| Renal Denervation Group | Experimental | Not described Receives: Procedure: Renal Denervation; Procedure: Renal Angiography |
| Sham Control Group | Sham comparator | Not described Receives: Procedure: Renal Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up
Measured: 6 months after intervention
Secondary outcomes (6)
The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up
Hypertension control without antihypertensive medication was defined as the absence of two consecutive adjudications by the Clinical Event Committee (CEC) indicating a need for oral antihypertensive therapy during the follow-up period. The CEC performed 7 adjudications throughout the study based on office blood pressure measurements obtained at biweekly visits. The CEC was blinded to treatment allocation.
Measured: 6 months after intervention
Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up
Measured: 6 months after intervention
Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Measured: 3/6/12 months after intervention
Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Measured: 3/612 months after intervention
The incidence of procedure-related adverse events and complications at 6-month follow-up
Procedure-related adverse events and complications include renal artery stenosis, major bleeding, non-stroke thromboembolic events, renal artery stenosis or dissection, access site complications, severe vascular complications, and rehospitalization for cardiovascular events.
Measured: 6 months after intervention
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up
MACCE includes cardiovascular and cerebrovascular mortality, stroke, and acute heart failure.
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (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.
- 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, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783296
- Sponsor's protocol ID
- STOP
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06783296
- Acronym / sponsor ID
- STOP
- Conditions
- Hypertension, Renal Denervation Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy and safety of renal denervation (RDN) in patients with isolated diastolic hypertension (IDH). The randomized, double-blind, sham-controlled, multicenter clinical trial will recruit 124 participants (62 in the treatment group and 62 in the sham control group) to assess changes in mean 24-hour ambulatory diastolic blood pressure over a 6-month follow-up period. The study is expected to provide evidence for the use of RDN as a treatment for IDH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Renal Denervation Group | Experimental | Procedure: Renal Denervation, Procedure: Renal Angiography |
| Sham Control Group | Sham comparator | Procedure: Renal Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years, with no restriction on sex or ethnicity;
- Diagnosis of primary hypertension, with no prior use of antihypertensive medication, and in the untreated state presenting with office systolic blood pressure (SBP) <140 mmHg and diastolic blood pressure (DBP) ≥90 mmHg, as well as 24-hour ambulatory blood pressure monitoring (ABPM) showing SBP <130 mmHg and DBP ≥80 mmHg;
- Willingness to participate and provision of written informed consent.
Key exclusion criteria (9 listed)
- DBP ≥110 mmHg;
- Secondary hypertension;
- Requirement for antihypertensive or blood pressure-lowering medications due to comorbid conditions (e.g., SGLT2 inhibitors, GLP-1 receptor agonists);
- Cardiac arrhythmias interfering with blood pressure measurement (e.g., atrial fibrillation);
- Contraindications to RDN, including renal transplantation, renal insufficiency (eGFR <45 mL/min/1.73 m²), renal artery anatomy unsuitable for the procedure (inability to access the renal vasculature; renal artery diameter <4 mm or length <20 mm; hemodynamically or anatomically significant renal artery abnormalities or stenosis; prior coronary or renal artery interventions including angioplasty or stenting), and severe hepatic impairment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Renal DenervationRenal denervation (RDN) was performed using radiofrequency ablation in the cardiac catheterization laboratory equipped with a digital subtraction angiography (DSA) system. Under intravenous anesthesia, femoral artery access was obtained and a renal denervation sheath was advanced. An ablation catheter was then introduced to both renal arteries, and ablations were applied across four quadrants to achieve circumferential denervation. Throughout the procedure, vital signs were continuously monitored, and vasodilators or anticholinergics (e.g., nitroglycerin, atropine) were prepared to prevent vascular spasm or related complications. After completion, the femoral access site was closed and compressed, and patients were returned to the ward following stabilization of vital signs. | Procedure or surgery | Renal Denervation Group |
| Renal AngiographyRenal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN. | Procedure or surgery | Renal Denervation Group, Sham Control Group |
Primary outcome
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up
Time frame: 6 months after intervention
6 secondary outcomes
The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up
Time frame: 6 months after intervention
Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up
Time frame: 6 months after intervention
Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Time frame: 3/6/12 months after intervention
Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Time frame: 3/612 months after intervention
The incidence of procedure-related adverse events and complications at 6-month follow-up
Time frame: 6 months after intervention
The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up
Time frame: 6 months after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renal Denervation and Renal Angiography in people with Hypertension and Renal Denervation Therapy, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (18917686332, yizshcn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up (time frame: 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.