Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Otsuka Medical Devices Co., Ltd. Japan

Conditions:

Hypertension

Vascular Diseases

Eligibility:

All Genders

20-75 years

Phase:

NA

Brief Summary

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...

Eligibility 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

Key Trial Info

Start Date :

July 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2032

Estimated Enrollment :

154 Patients enrolled

Trial Details

Trial ID

NCT05326230

Start Date

July 1 2022

End Date

December 1 2032

Last Update

April 15 2026

Active Locations (51)

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Page 1 of 13 (51 locations)

1

Hirosaki University Hospital

Hirosaki-shi, Aomori, Japan

2

Tokyo Bay Urayasu Ichikawa Medical Center

Urayasu-shi, Chiba, Japan

3

Ehime University Hospital

Toon-shi, Ehime, Japan

4

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan