Menu
Not yet recruiting NCT06783296

Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

No phase Interventional Hypertension Renal Denervation Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Renal Denervation, Renal Angiography.
Who it may be relevant to
Registry conditions: Hypertension, Renal Denervation Therapy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension: A Multicenter, Double-Blind, Randomized, Sham-Controlled Clinical Trial

Overview

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.

Interventions

  • Procedure 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 monitore
  • Procedure 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.

Primary outcome measures

  • Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up [Time frame: 6 months after intervention]
Secondary outcome measures (6)
  • The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up [Time frame: 6 months after intervention]
  • Changes in 24-hour ambulatory systolic/diastolic blood pressure (daytime, nighttime, and overall periods) at the 6-month follow-up [Time frame: 6 months after intervention]
  • Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up [Time frame: 3/6/12 months after intervention]
  • Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up [Time frame: 3/612 months after intervention]
  • The incidence of procedure-related adverse events and complications at 6-month follow-up [Time frame: 6 months after intervention]
  • The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and all-cause mortality at 6-month follow-up [Time frame: 6 months after intervention]

Eligibility criteria

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);
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Cardiology, Shanghai Tenth People's Hospital — Shanghai

Identifiers

NCT: NCT06783296 · STOP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗