Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

NCT06783296 | Not Yet Recruiting DMC

• 1 other identifier: STOP
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Renal Denervation Therapy

Outcome Measures

Primary Outcomes (1)

• Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up

  6 months after intervention

Secondary Outcomes (6)

• The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up

  6 months after intervention

• Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up

  6 months after intervention

• Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up

  3/6/12 months after intervention

• Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up

  3/612 months after intervention

• The incidence of procedure-related adverse events and complications at 6-month follow-up

  6 months after intervention

Study Arms (2)

Renal Denervation Group

EXPERIMENTAL

Procedure: Renal Denervation; Procedure: Renal Angiography

Sham Control Group

SHAM COMPARATOR

Procedure: Renal Angiography

Interventions

Renal Denervation PROCEDURE

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 Denervation Group

Renal Angiography PROCEDURE

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.

Renal Denervation Group; Sham Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yi Zhang

CONTACT

18917686332; yizshcn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of Medicine

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

CN (1)