Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension (NCT06783296) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
China124 participantsStarted 2026-01-01
Plain-language 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 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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);
✕. 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;
What they're measuring
1
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up