Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
Starting soon · Not applicable · Has a placebo group
Conditions studied: Hypertension, Renal Denervation Therapy
In brief
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.
Key facts
- Study ID
- NCT06783296
- Run by
- Shanghai 10th People's Hospital
- People needed
- 124
- Starts
- 2026-01-01
- Expected to finish
- 2028-07-31
- Last updated by the study team
- 2026-02-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
- Pregnancy, planning pregnancy, or breastfeeding;
- Life expectancy <1 year;
- Participation in another clinical trial.
Where it is running
- Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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