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
Qualifiers
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
Treatments tested in this trial
- Renal Denervation
- Renal Angiography
Treatment groups
124 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov