NCT06783296Not yet recruiting
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 14 Jan 2025
- Start date
- Jan 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Shanghai 10th People's Hospital
- Diseases
- High blood pressure
- NCT number
- NCT06783296
What you commit to
- Study type: Interventional
- Planned participants: 124
- From Jan 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
Lab values
- 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;
Other
- DBP ≥110 mmHg;
- Contraindications to interventional procedures such as coagulopathy;
- Pregnancy, planning pregnancy, or breastfeeding;
- Life expectancy \<1 year;
- Participation in another clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology, Shanghai Tenth People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.