Brief Summary

The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline

Completed

Started Jan 2017

Longer than P75 for phase_3 hypertension

Geographic Reach

2 countries

53 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.8 years study duration

First Submitted

Initial submission to the registry

September 27, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed

1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed

Last Updated

November 19, 2021

Status Verified

November 1, 2021

Enrollment Period

3.5 years

First QC Date

September 27, 2016

Last Update Submit

November 11, 2021

Conditions

Hypertension Vascular Diseases

Keywords

denervationresistant hypertension

Outcome Measures

Primary Outcomes (1)

a decrease of average 24-hr ambulatory systolic BP from the baseline
3 month follow-up visit

Secondary Outcomes (3)

a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively
3 month follow-up visit
a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively
3 month follow-up visit
a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline
3 month follow-up visit

Study Arms (2)

PRDS-001 Renal Denervation Ultrasound System

SHAM COMPARATOR

Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using PRDS-001 System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.

Device: PRDS-001 Renal Denervation Ultrasound System

Sham Procedure

SHAM COMPARATOR

Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.

Procedure: Sham Procedure

Interventions

PRDS-001 Renal Denervation Ultrasound SystemDEVICE

Also known as: renal denervation

PRDS-001 Renal Denervation Ultrasound System

Sham ProcedurePROCEDURE

Also known as: renal angiography

Sham Procedure

Eligibility Criteria

Age20 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)
hr ambulatory BP 140 mmHg or greater.

You may not qualify if:

Secondary hypertension (sleep apnoea can be included.)
Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater
Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)
eGFR\<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)
Known severe cardiovascular events within 3 months or severe cerebrovascular events
Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months
Concurrent persistent atrial fibrillation
Patients those who are on active implantable medical devices
Primary pulmonary hypertension
Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

JIMRO Co., Ltd.lead

Study Sites (53)

Unknown Facility

Hirosaki, Aomori, Japan

Location

Unknown Facility

Urayasu, Chiba, Japan

Location

Unknown Facility

Tōon, Ehime, Japan

Location

Unknown Facility

Chikushino-shi, Fukuoka, Japan

Location

Unknown Facility

Kasuga, Fukuoka, Japan

Location

Unknown Facility

Kitakyushu, Fukuoka, Japan

Location

Unknown Facility

Kurume, Fukuoka, Japan

Location

Unknown Facility

Sekimachi, Gifu, Japan

Location

Unknown Facility

Nayoro, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Tomakomai, Hokkaido, Japan

Location

Unknown Facility

Amagasaki, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Morioka, Iwate, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kahoku, Kanazawa, Japan

Location

Unknown Facility

Kōchi, Kochi, Japan

Location

Unknown Facility

Suzuka, Mie-ken, Japan

Location

Unknown Facility

Sendai, Miyagi, Japan

Location

Unknown Facility

Nakagami, Okinawa, Japan

Location

Unknown Facility

Kishiwada, Osaka, Japan

Location

Unknown Facility

Sakai, Osaka, Japan

Location

Unknown Facility

Suita, Osaka, Japan

Location

Unknown Facility

Sayama, Saitama, Japan

Location

Unknown Facility

Shimotsuke, Tochigi, Japan

Location

Unknown Facility

Adachi City, Tokyo, Japan

Location

Unknown Facility

Chiyoda City, Tokyo, Japan

Location

Unknown Facility

Hachiōji, Tokyo, Japan

Location

Unknown Facility

Meguro City, Tokyo, Japan

Location

Unknown Facility

Minato, Tokyo, Japan

Location

Unknown Facility

Minato-Ku, Tokyo, Japan

Location

Unknown Facility

Musashino, Tokyo, Japan

Location

Unknown Facility

Sakata, Yamagata, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Miyazaki, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Saga, Japan

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gangneung, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Yangsan, South Korea

Location

Related Publications (1)

Kario K, Yokoi Y, Okamura K, Fujihara M, Ogoyama Y, Yamamoto E, Urata H, Cho JM, Kim CJ, Choi SH, Shinohara K, Mukai Y, Ikemoto T, Nakamura M, Seki S, Matoba S, Shibata Y, Sugawara S, Yumoto K, Tamura K, Yoshihara F, Nakamura S, Kang WC, Shibasaki T, Dote K, Yokoi H, Matsuo A, Fujita H, Takahashi T, Kang HJ, Sakata Y, Horie K, Inoue N, Sasaki KI, Ueno T, Tomita H, Morino Y, Nojima Y, Kim CJ, Matsumoto T, Kai H, Nanto S. Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial. Hypertens Res. 2022 Feb;45(2):221-231. doi: 10.1038/s41440-021-00754-7. Epub 2021 Oct 15.
PMID: 34654905DERIVED

MeSH Terms

Conditions

HypertensionVascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

January 1, 2017

Primary Completion

July 1, 2020

Study Completion

October 1, 2021

Last Updated

November 19, 2021

Record last verified: 2021-11

Locations

JP(44)KR(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

PRDS-001 Renal Denervation Ultrasound System

Sham Procedure

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (53)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

Locations