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

Primary Purpose

Hypertension, Vascular Diseases, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Renal Angiogram
Sponsored by
Otsuka Medical Devices Co., Ltd. Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Denervation, Hypertension

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 COVID-19 infection within 3 months prior to obtaining consent

  • 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

Sites / Locations

  • Tokyo Bay Urayasu Ichikawa Medical Center
  • Fukuoka University Chikushi Hospital
  • Fukuoka Sanno HospitalRecruiting
  • Kurume University Hospital
  • Hiroshima City North Medical Center Asa Citizens Hospital
  • Kobe University Hospital
  • Nishinomiya Municipal Central Hospital
  • Kanazawa University Hospital
  • Yokohama Rosai Hospital
  • Chikamori Hospital
  • Japanese Red Cross Kumamoto HospitalRecruiting
  • Kumamoto University Hospital
  • Miyazaki Medical Association HospitalRecruiting
  • Niigata City General Hospital
  • Okayama Rosai Hospital
  • National Cerebral and Cardiovascular Center
  • Jichi Medical University Hospital
  • Mitsui Memorial Hospital
  • Minamino Junkanki Hospital
  • Toho University Medical Center Ohashi Hospital
  • Tokyo Saiseikai Central HospitalRecruiting
  • Toranomon Hospital
  • Nihonkai General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Renal Denervation

Sham Control

Arm Description

Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)

Renal Angiogram

Outcomes

Primary Outcome Measures

Mean change in 24-hour systolic ABPM

Secondary Outcome Measures

Mean change in 24-hour systolic ABPM
Mean change in daytime/nighttime /24-hour ABPM (systolic/diastolic) (excluding primary and important secondary endpoints)
Change in mean sitting office blood pressure (systolic/diastolic)
Change in mean home blood pressure (systolic/diastolic)
Percentage of subjects with a mean decrease in daytime/nighttime/24-hour systolic ABPM of ≥5 mmHg, ≥10 mmHg, and ≥15 mmHg
Percentage of subjects who required a change in antihypertensive medication
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Change in mean pulse pressure (difference between systolic and diastolic blood pressure) in the office, home, ABPM
Change in mean heart rate in the office, home, ABPM

Full Information

First Posted
April 6, 2022
Last Updated
June 15, 2022
Sponsor
Otsuka Medical Devices Co., Ltd. Japan
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1. Study Identification

Unique Protocol Identification Number
NCT05326230
Brief Title
A Clinical Study of the Paradise™ Renal Denervation System in Patients With Hypertension (RADIANCE-HTN DUO)
Official Title
A Clinical Study of the Ultrasound Renal Denervation System (PRDS-001) in Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Medical Devices Co., Ltd. Japan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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, and treated with a duo combination antihypertensive pill.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Vascular Diseases, Cardiovascular Diseases
Keywords
Denervation, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal Angiogram and Renal Denervation (PRDS-001- Paradise™ System)
Arm Title
Sham Control
Arm Type
Sham Comparator
Arm Description
Renal Angiogram
Intervention Type
Device
Intervention Name(s)
Paradise™ (PRDS-001) Renal Denervation Ultrasound System
Other Intervention Name(s)
Renal Angiogram/Renal Denervation
Intervention Description
Following renal angiogram according to standard procedures, subjects remain blinded and are randomized to treatment with renal denervation or sham control
Intervention Type
Device
Intervention Name(s)
Renal Angiogram
Intervention Description
Following renal angiogram according to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure
Primary Outcome Measure Information:
Title
Mean change in 24-hour systolic ABPM
Time Frame
From baseline to 3 months post-procedure
Secondary Outcome Measure Information:
Title
Mean change in 24-hour systolic ABPM
Time Frame
from baseline to 6 months post-procedure
Title
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
Title
Change in mean sitting office blood pressure (systolic/diastolic)
Time Frame
From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Title
Change in mean home blood pressure (systolic/diastolic)
Time Frame
From baseline to 1, 2, 3, 4, 5, 6, 9, 12, 24, 36, 48, 60 months post-procedure
Title
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
Title
Percentage of subjects who required a change in antihypertensive medication
Time Frame
at any time up to 12 months after the procedure
Title
Percentage of subjects who achieved blood pressure control without any change in antihypertensive medication
Time Frame
3, 6, 12 months after the procedure
Title
Percentage of subjects whose blood pressure was controlled by changing antihypertensive medication
Time Frame
3, 6, 12 months after the procedure
Title
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
Title
Change in mean heart rate in the office, home, ABPM
Time Frame
3, 6, 12 months after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 COVID-19 infection within 3 months prior to obtaining consent 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mikiko Haraguchi
Phone
+81 3 6361 7459
Email
OtsukaRegistry-CT@otsuka.jp
Facility Information:
Facility Name
Tokyo Bay Urayasu Ichikawa Medical Center
City
Urayasu-shi
State/Province
Chiba
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino-shi
State/Province
Fukuoka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Fukuoka Sanno Hospital
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Kurume University Hospital
City
Kurume-shi
State/Province
Fukuoka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Hiroshima City North Medical Center Asa Citizens Hospital
City
Hiroshima-shi
State/Province
Hiroshima
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Kobe University Hospital
City
Kobe-shi
State/Province
Hyogo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Nishinomiya Municipal Central Hospital
City
Nishinomiya-Shi
State/Province
Hyogo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Kanazawa University Hospital
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Yokohama Rosai Hospital
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Chikamori Hospital
City
Kochi-shi
State/Province
Kochi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Japanese Red Cross Kumamoto Hospital
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Kumamoto University Hospital
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Miyazaki Medical Association Hospital
City
Miyazaki-shi
State/Province
Miyazaki
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Niigata City General Hospital
City
Niigata-shi
State/Province
Niigata
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Okayama Rosai Hospital
City
Okayama-shi
State/Province
Okayama
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
National Cerebral and Cardiovascular Center
City
Suita-shi
State/Province
Osaka
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikoko Haraguchi
Facility Name
Jichi Medical University Hospital
City
Shimotuke-shi
State/Province
Tochigi
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Mitsui Memorial Hospital
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Minamino Junkanki Hospital
City
Hachioji-shi, Tokyo
State/Province
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Toho University Medical Center Ohashi Hospital
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Tokyo Saiseikai Central Hospital
City
Minato-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Toranomon Hospital
City
Minato-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi
Facility Name
Nihonkai General Hospital
City
Sakata-shi
State/Province
Yamagata
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikiko Haraguchi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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