Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

Tongji University

Status: Not yet enrolling

Conditions: Hypertension; Renal Denervation Therapy

Treatments: Procedure: Renal Denervation; Procedure: Renal Angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT06783296

STOP

Details and patient eligibility

About

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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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124 participants in 2 patient groups

Renal Denervation Group

Experimental group

Treatment:

Procedure: Renal Angiography

Procedure: Renal Denervation

Sham Control Group

Sham Comparator group

Treatment:

Procedure: Renal Angiography