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NCT Number: NCT06783296

Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Changes in mean 24-hour ambulatory diastolic blood pressure at 6-month follow-up

    Time frame: 6 months after intervention

Secondary outcomes

  1. The proportion of patients achieving hypertension control without antihypertensive medication at the 6-month follow-up

    Time frame: 6 months after intervention

    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.

  2. 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

  3. Changes in office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up

    Time frame: 3/6/12 months after intervention

  4. Changes in home/office systolic/diastolic blood pressure at 3, 6, and 12 months of follow-up

    Time frame: 3/612 months after intervention

  5. The incidence of procedure-related adverse events and complications at 6-month follow-up

    Time frame: 6 months after intervention

    Procedure-related adverse events and complications include renal artery stenosis, major bleeding, non-stroke thromboembolic events, renal artery stenosis or dissection, access site complications, severe vascular complications, and rehospitalization for cardiovascular events.

  6. 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

    MACCE includes cardiovascular and cerebrovascular mortality, stroke, and acute heart failure.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhang

CONTACT

[email protected]

18917686332

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 20, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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