Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-04-22 @ 8:55 PM
Study NCT ID:
NCT02362893
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2015-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-27', 'studyFirstSubmitDate': '2015-02-09', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 24-hour ambulatory mean systolic daytime blood pressure', 'timeFrame': 'Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.'}], 'secondaryOutcomes': [{'measure': 'Change in mean office systolic blood pressure', 'timeFrame': 'Measurement at follow-up visit 3 weeks ± 7 days relative to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Adherence', 'Direct Observed Therapy (DOT)', 'RCT'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '23836798', 'type': 'BACKGROUND', 'citation': 'Fadl Elmula FE, Hoffmann P, Fossum E, Brekke M, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Kjeldsen SE, Os I, Stenehjem AE, Hoieggen A. Renal sympathetic denervation in patients with treatment-resistant hypertension after witnessed intake of medication before qualifying ambulatory blood pressure. Hypertension. 2013 Sep;62(3):526-32. doi: 10.1161/HYPERTENSIONAHA.113.01452. Epub 2013 Jul 8.'}, {'pmid': '24591332', 'type': 'BACKGROUND', 'citation': 'Fadl Elmula FE, Hoffmann P, Larstorp AC, Fossum E, Brekke M, Kjeldsen SE, Gjonnaess E, Hjornholm U, Kjaer VN, Rostrup M, Os I, Stenehjem A, Hoieggen A. Adjusted drug treatment is superior to renal sympathetic denervation in patients with true treatment-resistant hypertension. Hypertension. 2014 May;63(5):991-9. doi: 10.1161/HYPERTENSIONAHA.114.03246. Epub 2014 Mar 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to access the change in mean daytime systolic blood pressure in participants with essential hypertension not adequately controlled (defined as mean systolic daytime ambulatory blood pressure ≥ 135 mmHg) and randomly assigned to either an intervention group with one-time only Direct Observed Therapy (DOT) immediately followed by ABPM or a control group with standard ABPM.', 'detailedDescription': 'More than 1 billion people world wide suffer from hypertension (HT), leaving it the world´s top rank risk factor and contributor to global disease burden. Cardiac disease, stroke, kidney disease and dementia are diseases related to HT with high economic burden on societies and each year 9.4 million people die as a direct consequence of HT.\n\nEstimated \\< 50 % of hypertensive patients adhere to preventive hypertensive medication after 1 year of treatment.\n\nPoor adherence to antihypertensive treatment have by many been explained partly by the silent nature of hypertension, the risk of side effects from antihypertensive medication, treatment expenditures and the patient health perspectives.\n\nIn a randomized controlled trial design we plan to enrol 20 subjects, the limited number explained by the study being part of the initial planning of a larger scale trial organized by the research group, to invistigate the change in ambulatory bloodpressure with or with out Direct Observed Theraphy prior to meassurement, as a one-time-only medication adherence check.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and above\n* Residing in Oslo/Akershus\n* Ambulatory Systolic Daytime Blood Pressure ≥ 135 mmHg\n* ≥ 2 antihypertensive medications\n* Be able to read and write Norwegian\n\nExclusion Criteria:\n\n* Critical illness, ongoing treatment\n* Known atrial fibrillation\n* Known heart valve stenosis\n* Myocardial infarction, angina pectoris or stroke the past 6 months\n* Known severe renal impairment (eGFR \\< 30 ml/min/1.73 m2)\n* History of DOT prior to ABPM\n* Participation in other interventional study'}, 'identificationModule': {'nctId': 'NCT02362893', 'acronym': 'DRIVE', 'briefTitle': 'Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Treatment of Hypertension: an Interventional Approach to Improve Blood Pressure Control', 'orgStudyIdInfo': {'id': '2015/159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Direct Observed Therapy', 'description': 'Direct Observed Therapy immediately followed by mounting of ambulatory blood pressure device and measurement of ambulatory blood pressure according to ESH 2013 guidelines.', 'interventionNames': ['Other: Direct Observed Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard care'}], 'interventions': [{'name': 'Direct Observed Therapy', 'type': 'OTHER', 'otherNames': ['DOT'], 'description': 'Patients allocated to the intervention group take their medication (from original blister packaged) in front of the invistigator who observe the patient swallowing the medication. To secure the principals of Direct Observed Therapy, the patient do not leave the clinic for two hours.', 'armGroupLabels': ['Direct Observed Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Aud Høieggen, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RN MSc', 'investigatorFullName': 'Ulla Hjørnholm', 'investigatorAffiliation': 'Oslo University Hospital'}}}}