Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2026-02-26 @ 7:51 PM
Study NCT ID:
NCT02918305
Status:
COMPLETED
Last Update Posted:
2021-11-19
First Post:
2016-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-11', 'studyFirstSubmitDate': '2016-09-27', 'studyFirstSubmitQcDate': '2016-09-27', 'lastUpdatePostDateStruct': {'date': '2021-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a decrease of average 24-hr ambulatory systolic BP from the baseline', 'timeFrame': '3 month follow-up visit'}], 'secondaryOutcomes': [{'measure': 'a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively', 'timeFrame': '3 month follow-up visit'}, {'measure': 'a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively', 'timeFrame': '3 month follow-up visit'}, {'measure': 'a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline', 'timeFrame': '3 month follow-up visit'}]}, 'conditionsModule': {'keywords': ['denervation', 'resistant hypertension'], 'conditions': ['Hypertension', 'Vascular Diseases']}, 'referencesModule': {'references': [{'pmid': '34654905', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)\n* 24-hr ambulatory BP 140 mmHg or greater.\n\nExclusion Criteria:\n\n* Secondary hypertension (sleep apnoea can be included.)\n* Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater\n* Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)\n* eGFR\\<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)\n* Known severe cardiovascular events within 3 months or severe cerebrovascular events\n* Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months\n* Concurrent persistent atrial fibrillation\n* Patients those who are on active implantable medical devices\n* Primary pulmonary hypertension\n* Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media"}, 'identificationModule': {'nctId': 'NCT02918305', 'acronym': 'REQUIRE', 'briefTitle': 'Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'JIMRO Co., Ltd.'}, 'officialTitle': 'A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension', 'orgStudyIdInfo': {'id': 'RDN-15-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'PRDS-001 Renal Denervation Ultrasound System', 'description': '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.', 'interventionNames': ['Device: PRDS-001 Renal Denervation Ultrasound System']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Procedure', 'description': 'Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.', 'interventionNames': ['Procedure: Sham Procedure']}], 'interventions': [{'name': 'PRDS-001 Renal Denervation Ultrasound System', 'type': 'DEVICE', 'otherNames': ['renal denervation'], 'armGroupLabels': ['PRDS-001 Renal Denervation Ultrasound System']}, {'name': 'Sham Procedure', 'type': 'PROCEDURE', 'otherNames': ['renal angiography'], 'armGroupLabels': ['Sham Procedure']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hirosaki', 'state': 'Aomori', 'country': 'Japan', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'city': 'Urayasu', 'state': 'Chiba', 'country': 'Japan', 'geoPoint': {'lat': 35.65879, 'lon': 139.90055}}, {'city': 'Tōon', 'state': 'Ehime', 'country': 'Japan', 'geoPoint': {'lat': 33.79427, 'lon': 132.89011}}, {'city': 'Chikushino-shi', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.49631, 'lon': 130.5156}}, {'city': 'Kasuga', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.52594, 'lon': 130.4611}}, {'city': 'Kitakyushu', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.85181, 'lon': 130.85034}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Sekimachi', 'state': 'Gifu', 'country': 'Japan', 'geoPoint': {'lat': 35.48333, 'lon': 136.91667}}, {'city': 'Nayoro', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 44.35056, 'lon': 142.45778}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Tomakomai', 'state': 'Hokkaido', 'country': 'Japan', 'geoPoint': {'lat': 42.63694, 'lon': 141.60333}}, {'city': 'Amagasaki', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71667, 'lon': 135.41667}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Nishinomiya', 'state': 'Hyōgo', 'country': 'Japan', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Kanazawa', 'state': 'Ishikawa-ken', 'country': 'Japan', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'city': 'Morioka', 'state': 'Iwate', 'country': 'Japan', 'geoPoint': {'lat': 39.7, 'lon': 141.15}}, {'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'city': 'Kahoku', 'state': 'Kanazawa', 'country': 'Japan', 'geoPoint': {'lat': 36.75758, 'lon': 136.71162}}, {'city': 'Kōchi', 'state': 'Kochi', 'country': 'Japan'}, {'city': 'Suzuka', 'state': 'Mie-ken', 'country': 'Japan', 'geoPoint': {'lat': 34.88333, 'lon': 136.58333}}, {'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'city': 'Nakagami', 'state': 'Okinawa', 'country': 'Japan'}, {'city': 'Kishiwada', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.46667, 'lon': 135.36667}}, {'city': 'Sakai', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.58216, 'lon': 135.46653}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Sayama', 'state': 'Saitama', 'country': 'Japan', 'geoPoint': {'lat': 35.85295, 'lon': 139.41212}}, {'city': 'Shimotsuke', 'state': 'Tochigi', 'country': 'Japan', 'geoPoint': {'lat': 36.41323, 'lon': 139.86622}}, {'city': 'Adachi City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.76318, 'lon': 139.80761}}, {'city': 'Chiyoda City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.68449, 'lon': 139.75056}}, {'city': 'Hachiōji', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.65583, 'lon': 139.32389}}, {'city': 'Meguro City', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6322, 'lon': 139.70174}}, {'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'city': 'Minato-Ku', 'state': 'Tokyo', 'country': 'Japan'}, {'city': 'Musashino', 'state': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.70611, 'lon': 139.55944}}, {'city': 'Sakata', 'state': 'Yamagata', 'country': 'Japan', 'geoPoint': {'lat': 38.91667, 'lon': 139.855}}, {'city': 'Fukuoka', 'country': 'Japan', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Hiroshima', 'country': 'Japan', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Kagoshima', 'country': 'Japan', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'city': 'Kumamoto', 'country': 'Japan', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'city': 'Kyoto', 'country': 'Japan', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Miyazaki', 'country': 'Japan', 'geoPoint': {'lat': 31.91667, 'lon': 131.41667}}, {'city': 'Niigata', 'country': 'Japan', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'city': 'Okayama', 'country': 'Japan', 'geoPoint': {'lat': 34.65, 'lon': 133.93333}}, {'city': 'Saga', 'country': 'Japan', 'geoPoint': {'lat': 33.23333, 'lon': 130.3}}, {'city': 'Busan', 'country': 'South Korea', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Gangneung', 'country': 'South Korea', 'geoPoint': {'lat': 37.75266, 'lon': 128.87239}}, {'city': 'Gwangju', 'country': 'South Korea', 'geoPoint': {'lat': 35.15472, 'lon': 126.91556}}, {'city': 'Gyeonggi-do', 'country': 'South Korea', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'city': 'Incheon', 'country': 'South Korea', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Yangsan', 'country': 'South Korea', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JIMRO Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}