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NCT Number: NCT05326230

A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)

To compare the antihypertensive effect of renal denervation with the Paradise™ system with that of a sham procedure in hypertensive patients receiving two antihypertensive drugs at the time of consent, and treated with a duo combination antihypertensive pill.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hirosaki University Hospital, Hirosaki-shi, Aomori, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Paradise™ (PRDS-001) Renal Denervation Ultrasound System

Device

Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control

Other names: Renal Angiogram/Renal Denervation

Renal Angiogram

Device

Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure

Primary outcomes

  1. Mean change in 24-hour systolic ABPM

    Time frame: From baseline to 3 months post-procedure

Secondary outcomes

  1. Mean change in 24-hour systolic ABPM

    Time frame: from baseline to 6 months post-procedure

  2. Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)

    Time frame: From baseline to 3, 6, 12 months post-procedure

  3. Change in mean sitting office blood pressure (systolic/diastolic)

    Time frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure

  4. Change in mean home blood pressure (systolic/diastolic)

    Time frame: From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36 months post-procedure

  5. Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg

    Time frame: 3, 6, and 12months post-procedure

  6. Percentage of subjects who required a change in antihypertensive medication

    Time frame: at any time up to 12 months after the procedure

  7. Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication

    Time frame: 3, 6, 12 months after the procedure

  8. Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication

    Time frame: 3, 6, 12 months after the procedure

  9. Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM

    Time frame: 3, 6, 12 months after the procedure

  10. Change in mean heart rate in the office, home, ABPM

    Time frame: 3, 6, 12 months after the procedure

Sponsors and collaborators

Lead sponsor

Otsuka Medical Devices Co., Ltd. Japan

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2032
First posted
Apr 13, 2022
Registry last updated
Apr 15, 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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