Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
NCT ID: NCT06783296
Last Updated: 2025-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
87 participants
INTERVENTIONAL
2025-10-01
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Renal Denervation Group
Patients receiving renal denervation using the Symplicity Spyral™ multi-electrode renal denervation system.
Renal Denervation
Renal denervation performed using the Symplicity Spyral™ multi-electrode renal denervation system, which is approved for interventional treatment of hypertension. This procedure involves catheter-based radiofrequency ablation of the renal nerves to reduce sympathetic activity and lower blood pressure.
Renal Angiography
A sham procedure involving renal angiography without the application of radiofrequency energy. This control intervention is used to maintain blinding.
Sham Control Group
Patients undergoing renal angiography only (sham procedure).
Renal Angiography
A sham procedure involving renal angiography without the application of radiofrequency energy. This control intervention is used to maintain blinding.
Interventions
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Renal Denervation
Renal denervation performed using the Symplicity Spyral™ multi-electrode renal denervation system, which is approved for interventional treatment of hypertension. This procedure involves catheter-based radiofrequency ablation of the renal nerves to reduce sympathetic activity and lower blood pressure.
Renal Angiography
A sham procedure involving renal angiography without the application of radiofrequency energy. This control intervention is used to maintain blinding.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with isolated diastolic hypertension (office SBP \< 140 mmHg and DBP ≥ 90 mmHg, and 24-hour average SBP \< 130 mmHg and DBP ≥ 80mmHg without antihypertensive medication).
3. Signed informed consent.
Exclusion Criteria
2. Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation).
3. Comorbidities such as diabetes, chronic kidney disease (eGFR \< 30 mL/min/1.73m²), coronary artery disease, heart failure, or serious valvular heart disease.
4. History of stroke or myocardial infarction.
5. Known bleeding disorders or inability to tolerate anticoagulation.
6. Inability to access the renal artery; renal artery diameter \< 4 mm or length \< 20 mm; hemodynamically or anatomically significant renal artery abnormalities or stenosis; a history of coronary or renal artery interventions.
7. Pregnancy, breastfeeding, or planning to become pregnant.
8. Life expectancy \< 1 year.
9. Participation in another clinical trial.
18 Years
45 Years
ALL
No
Sponsors
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Shanghai 10th People's Hospital
OTHER
Responsible Party
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Ya-Wei Xu
professor of Medicine
Locations
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Department of Cardiology, Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STOP
Identifier Type: -
Identifier Source: org_study_id
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