Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-27 @ 7:07 PM
Study NCT ID:
NCT02042066
Status:
UNKNOWN
Last Update Posted:
2014-01-22
First Post:
2014-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C563514', 'term': 'Hypertension Resistant to Conventional Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-21', 'studyFirstSubmitDate': '2014-01-19', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ambulatory Blood Pressure Monitoring (ABPM)', 'timeFrame': '6 Months', 'description': 'Change in 24 hour ambulatory blood pressure (ABPM) from baseline to six months post last treatment (± 2 weeks)'}, {'measure': 'Ambulatory Blood Pressure Monitoring (ABPM)', 'timeFrame': '3 Months', 'description': 'Change in 24 hour ambulatory blood pressure (ABPM) from baseline to three months post last treatment (± 2 weeks)'}], 'secondaryOutcomes': [{'measure': 'Office Blood Pressure', 'timeFrame': '6 Months', 'description': 'Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).'}, {'measure': 'Serum Urea and Creatinine', 'timeFrame': '3 Months', 'description': 'Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment'}, {'measure': 'Ultrasound', 'timeFrame': '3 Months', 'description': 'Change in ultrasound-measured renal resistive index (RRI)'}, {'measure': 'Serum Urea and Creatinine', 'timeFrame': '6 Months', 'description': 'Change in serum urea and creatinine from baseline to 3 months and 6 months (± 2 weeks) post last treatment'}, {'measure': 'Adverse Events', 'timeFrame': '6 Months'}, {'measure': 'Office Blood Pressure', 'timeFrame': '3 Months', 'description': 'Change in office blood pressure from baseline to three months and six months post last treatment (± 2 weeks).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Resistant Hypertension', 'RH', 'RHT', 'Blood Pressure', 'Kidney', 'Shockwave'], 'conditions': ['Hypertension, Resistant to Conventional Therapy']}, 'descriptionModule': {'briefSummary': 'Low intensity shockwaves have been proven in animal and human studies to increase tissue perfusion, promote angiogenesis and tissue regeneration and improve neural function.\n\nThe hypothesis of this study is that shockwave therapy could improve the symptoms of patients with resistant hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who have provided written informed consent.\n* Age ≥18 and ≤80 years old.\n* Office systolic blood pressure that remains ≥160 mmHg (≥150 mmHg for patient with type 2 diabetes) despite the stable use of ≥3 antihypertensive medications concurrently at maximally tolerated doses, of which one is a diuretic (unless there is a tolerance or a contraindication for a diuretics).\n* Able and willing to comply with the required follow-up schedule.\n\nExclusion Criteria:\n\n* Subjects who have participated in a clinical study involving another investigational drug or device within 4 weeks prior to Screening.\n* Have hypertension secondary to an identifiable and treatable cause or take medication that can raise the BP.\n* Prior renal artery intervention (balloon angioplasty or stenting).\n* Pregnancy.\n* Uncompensated heart failure.\n* Chronic Liver Disease.\n* Patients with skin wound / infection at the treatment area.\n* Subjects who take oral anti-coagulants.\n* Local tumor of treatment area.'}, 'identificationModule': {'nctId': 'NCT02042066', 'acronym': 'RHT', 'briefTitle': 'Safety and Efficacy Study of Extracorporeal Shockwave Therapy in the Treatment of Patients With Resistant Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medispec'}, 'officialTitle': 'Efficacy and Safety of Low Intensity- Extracorporeal Shockwave Therapy in Drug Resistant Hypertension', 'orgStudyIdInfo': {'id': 'RHT-01'}, 'secondaryIdInfos': [{'id': '0449-13', 'type': 'OTHER', 'domain': 'The Department of Clinical Trials - Israel, Hadassah Helsinki Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treated Group', 'description': 'This group will receive actual shockwave treatment', 'interventionNames': ['Device: Omnispec model Vascuspec']}], 'interventions': [{'name': 'Omnispec model Vascuspec', 'type': 'DEVICE', 'otherNames': ['Vascuspec'], 'description': 'Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy', 'armGroupLabels': ['Treated Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Ayelet Shauer, MD', 'role': 'CONTACT', 'email': 'aye.shauer@gmail.com', 'phone': '+972-2-6776564'}, {'name': 'Ayelet Shauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'David Libovitz, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ido Ben-Dov, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shmuel Hen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amir Orlev, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Ayelet Shauer, MD', 'role': 'CONTACT', 'email': 'aye.shauer@gmail.com', 'phone': '+972-2-6776564'}], 'overallOfficials': [{'name': 'Ayelet Shauer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medispec', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hadassah Medical Organization', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}