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Renal denervation for treating hypertension

A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients with Hypertension

NA · Otsuka Medical Devices Co., Ltd. Japan · NCT05326230

This study is testing whether a new ultrasound treatment can help lower blood pressure in people with hypertension who are already taking two blood pressure medications.

Quick facts

PhaseNA
Study typeInterventional
Enrollment154 (estimated)
Ages20 Years to 75 Years
SexAll
SponsorOtsuka Medical Devices Co., Ltd. Japan (industry)
Locations51 sites (Hirosaki-shi, Aomori and 50 other locations)
Trial IDNCT05326230 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of the Paradise™ Renal Denervation System in reducing blood pressure in patients with hypertension who are already on two antihypertensive medications. Participants will be compared against a sham procedure to assess the true impact of the renal denervation. The study focuses on patients with specific blood pressure measurements and aims to determine if this innovative approach can provide better control of hypertension. The intervention involves the use of ultrasound technology to target renal nerves.

Who should consider this trial

Good fit: Ideal candidates are adults with hypertension who are currently taking two antihypertensive medications and have specific blood pressure readings.

Not a fit: Patients with secondary hypertension, certain diabetes conditions, or recent severe cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for patients struggling to manage their hypertension.

How similar studies have performed: Previous studies on renal denervation have shown promise, but this specific approach with the Paradise™ system is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria :

* Patients who have received antihypertensive treatment with two antihypertensive drugs (ARB/ACE inhibitor and Ca channel antagonist, either as a single agent or as a combination) for at least 4 weeks prior to obtaining consent, with no change in the type or dosage.
* Patients with a mean seated office blood pressure of between 140 mmHg and 180 mmHg systolic and between 90 mmHg and 110 mmHg diastolic at screening visit.
* Patients with a mean 24-hour ABPM (ambulatory blood pressure measurement) of between 130 mmHg and 170 mmHg systolic and between 80 mmHg and 105 mmHg diastolic at baseline visit

Exclusion Criteria

* Lacks appropriate renal artery anatomy for renal denervation
* Secondary hypertension other than sleep apnea
* Type 1 diabetes mellitus or uncontrolled Type 2 diabetes
* Any history of cerebrovascular event or severe cardiovascular event, within 6 months prior to consent
* Repeated hospitalization for hypertensive crisis (twice or more) within 12 months prior to obtaining consent, or any hospitalization for hypertensive crisis within 3 months prior to obtaining consent
* Patients prescribed to drugs that have antihypertensive effects for other chronic diseases, and the investigator considers that discontinuation of these drugs may pose a serious risk to health
* Patients who are taking drugs known to affect blood pressure and the investigator judges that it is not possible to discontinue these drugs during the study period
* Patients with a history of persistent or permanent atrial tachyarrhythmia
* Patients with active implantable medical devices
* Primary pulmonary hypertension
* Patients with contraindications or unacceptable anaphylactic reactions or uncontrolled allergy to contrast media
* Night shift workers
* Pregnant, nursing or planning to become pregnant
* Patients with any of the following central laboratory tests at screening

  * Plasma aldosterone/renin ratio greater than or equal to 200 and plasma aldosterone greater than or equal to 60 pg/ml
  * HbA1c greater than or equal to 8.0%
  * eGFR less than 40 mL/min/1.73m2

Where this trial is running

Hirosaki-shi, Aomori and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Hypertension, Vascular Diseases, Cardiovascular Diseases, Denervation

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.