---
title: Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
nct_id: NCT06783296
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: "Shanghai 10th People's Hospital"
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06783296.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06783296"
ct_last_update_post_date: 2026-02-02
last_seen_at: "2026-05-12T06:59:26.014Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

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

**NCT ID:** [NCT06783296](https://clinicaltrials.gov/study/NCT06783296)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 124
- **Lead Sponsor:** Shanghai 10th People's Hospital
- **Conditions:** Hypertension, Renal Denervation Therapy
- **Start Date:** 2026-01-01
- **Completion Date:** 2028-07-31
- **CT.gov Last Update:** 2026-02-02

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Renal Denervation Group** (EXPERIMENTAL)
- **Sham Control Group** (SHAM_COMPARATOR)

## 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 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.

## Primary Outcomes

- **Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up** _(time frame: 6 months after intervention)_

## Secondary Outcomes

- **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)_

## Locations (1)

- Department of Cardiology, Shanghai Tenth People's Hospital, Shanghai, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.department of cardiology, shanghai tenth people's hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_

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