Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

NCT06783296 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai 10th People's Hospital

Phase

Not applicable

Started

2026-01-01

Last updated

2026-02-02

Condition(s) studied

HypertensionRenal Denervation Therapy

Investigational drug(s) / intervention(s)

Renal DenervationRenal Angiography

Renal Denervation: 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 Angiography: 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 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria 1. Age ≥18 years, with no restriction on sex or ethnicity; 2. 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; 3. Willingness to participate and provision of written informed consent. Exclusion Criteria 1. DBP ≥110 mmHg; 2. Secondary hypertension; 3. Requirement for antihypertensive or blood pressure-lowering medications due to comorbid conditions (e.g., SGLT2 inhibitors, GLP-1 receptor agonists); 4. Cardiac arrhythmias interfering with blood pressure measurement (e.g., atrial fibrillation); 5. 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; 6. Contraindications to interventional procedures such as coagulopathy; 7. Pregnancy, planning pregnancy, or breastfeeding; 8. Life expectancy \<1 year; 9. Participation in another clinical trial.

Primary outcome measure(s)

Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up — 6 months after intervention

Trial sites (1)

Facility	City	Region	Status
Department of Cardiology, Shanghai Tenth People's Hospital	Shanghai	Shanghai Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06783296 on ClinicalTrials.gov ↗ ← All trials in China