Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai 10th People's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Renal Denervation
Procedure/SurgeryRenal 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
Procedure/SurgeryRenal angiography was performed under intravenous anesthesia via femoral artery access, and the procedure lasted approximately 1 hour to simulate the duration of active RDN.
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: Renal Denervation GroupExperimental treatment 2 interventions
Group B: Sham Control GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up
Time frame
6 months after interventionSecondary outcomes
1
The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up
Hypertension control without antihypertensive medication was defined as the absence of two consecutive adjudications by the Clinical Event Committee (CEC) indicating a need for oral antihypertensive therapy during the follow-up period. The CEC performed 7 adjudications throughout the study based on office blood pressure measurements obtained at biweekly visits. The CEC was blinded to treatment allocation.
Time frame
6 months after intervention2
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 intervention3
Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Time frame
3/6/12 months after intervention4
Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up
Time frame
3/612 months after interventionSponsors and contacts
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Source ClinicalTrials.gov
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