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HypertensionPhase 3REQUIRENCT02918305

Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension

A Phase 3 study testing PRDS-001 Renal Denervation Ultrasound System in people with Hypertension and Vascular Diseases, run by JIMRO Co., Ltd. at 53 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Hypertension, Vascular Diseases
What is being tested?
PRDS-001 Renal Denervation Ultrasound System
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
53 sitesin 2 countries
Study dates
Jan 2017to Oct 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

Japan44 sites

  • Study site

    Adachi City, Tokyo

  • Study site

    Amagasaki, Hyōgo

  • Study site

    Chikushino-shi, Fukuoka

  • Study site

    Chiyoda City, Tokyo

  • Study site

    Fukuoka

  • Study site

    Hachiōji, Tokyo

  • Study site

    Hirosaki, Aomori

  • Study site

    Hiroshima

  • Study site

    Kagoshima

  • Study site

    Kahoku, Kanazawa

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kasuga, Fukuoka

  • Study site

    Kishiwada, Osaka

  • Study site

    Kitakyushu, Fukuoka

  • Study site

    Kobe, Hyōgo

  • Study site

    Kōchi, Kochi

  • Study site

    Kumamoto

  • Study site

    Kurume, Fukuoka

  • Study site

    Kyoto

  • Study site

    Meguro City, Tokyo

  • Study site

    Minato, Tokyo

  • Study site

    Minato-Ku, Tokyo

  • Study site

    Miyazaki

  • Study site

    Morioka, Iwate

  • Study site

    Musashino, Tokyo

  • Study site

    Nakagami, Okinawa

  • Study site

    Nayoro, Hokkaido

  • Study site

    Niigata

  • Study site

    Nishinomiya, Hyōgo

  • Study site

    Okayama

  • Study site

    Saga

  • Study site

    Sakai, Osaka

  • Study site

    Sakata, Yamagata

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sayama, Saitama

  • Study site

    Sekimachi, Gifu

  • Study site

    Sendai, Miyagi

  • Study site

    Shimotsuke, Tochigi

  • Study site

    Suita, Osaka

  • Study site

    Suzuka, Mie-ken

  • Study site

    Tomakomai, Hokkaido

  • Study site

    Tōon, Ehime

  • Study site

    Urayasu, Chiba

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

South Korea9 sites

  • Study site

    Busan

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Gangneung

  • Study site

    Gwangju

  • Study site

    Gyeonggi-do

  • Study site

    Incheon

  • Study site

    Seoul

  • Study site

    Yangsan

Other trials in South Korea

About this study

Official title: A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension

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.

Read the detailed description

Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.

Being tested
PRDS-001 Renal Denervation Ultrasound System, Sham Procedure
Keywords
denervation, resistant hypertension
Medical subject headings
Hypertension, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRDS-001 Renal Denervation Ultrasound SystemDevice

    Also called renal denervation

  • Sham ProcedureProcedure or surgery

    Also called renal angiography

Study groups in NCT02918305
Study groupRoleWhat they receive
PRDS-001 Renal Denervation Ultrasound SystemSham comparatorRandomization 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.
Receives: Device: PRDS-001 Renal Denervation Ultrasound System
Sham ProcedureSham comparatorRandomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.
Receives: Procedure: Sham Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. a decrease of average 24-hr ambulatory systolic BP from the baseline

    Measured: 3 month follow-up visit

Secondary outcomes (3)

  1. a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively

    Measured: 3 month follow-up visit

  2. a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively

    Measured: 3 month follow-up visit

  3. a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline

    Measured: 3 month follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionJul 2020
  4. Study completionOct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02918305
Sponsor's protocol ID
RDN-15-001
Acronym
REQUIRE
Status last verified
Nov 2021
First submitted
27 Sep 2016
Last updated
19 Nov 2021
Results posted
No

Publications

  • 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.

    PubMed 34654905

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRDS-001 Renal Denervation Ultrasound System in people with Hypertension and Vascular Diseases, run by JIMRO Co., Ltd. at 53 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Japan, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

a decrease of average 24-hr ambulatory systolic BP from the baseline (time frame: 3 month follow-up visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02918305, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.

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