Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06132451
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-Hospital Detection of Elevated Blood Pressure
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': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'In the first block, the treating physicians will not be informed about the study participation of their patient, in order to ensure that they will treat the patient according to what they perceive as the current usual practice. In the second block, the treating physicians will be informed about the study participation of their patients.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be block-wise randomization. During the first block, the study team will not interfere with the treating physician, in order to ensure that they will treat the patient according to what they perceive as the current usual practice. During the second block the patients receive no change of their original antihypertensive treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-16', 'studyFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of persisting new or uncontrolled arterial hypertension', 'timeFrame': '4 weeks after hospital discharge', 'description': 'Elevated blood pressure values in ambulatory blood pressure monitoring'}, {'measure': 'Prevalence of a combined hypertensive complication endpoint', 'timeFrame': 'Until 4 weeks after hospital discharge', 'description': 'Consisting of intracerebral bleeding, ischemic stroke, myocardial infarction, cardiovascular death or cardiovascular re-hospitalization'}, {'measure': 'Prevalence of a combined hypotensive complication endpoint', 'timeFrame': 'Until 4 weeks after hospital discharge', 'description': 'Consisting of falls, acute kidney injury, electrolyte disturbances, re-hospitalizations due to hypotension, or BP values on ABPM below the lower treatment limit'}], 'secondaryOutcomes': [{'measure': 'Clinic blood pressure measurement in mmHg', 'timeFrame': 'At baseline', 'description': 'Documented in the patient documentation'}, {'measure': 'Research blood pressure measurement in mmHg', 'timeFrame': 'At baseline', 'description': 'Standardized blood pressure measurement taken by research staff'}, {'measure': 'Prevalence of previously unknown arterial hypertension', 'timeFrame': 'At baseline', 'description': 'No previously documented diagnosis of arterial hypertension and no antihypertensive treatment'}, {'measure': 'Prevalence of female gender', 'timeFrame': 'At baseline', 'description': 'As reported by participant'}, {'measure': 'Prevalence of re-hospitalization for any cause', 'timeFrame': 'Until 4 weeks after hospital discharge', 'description': 'According to hospital documentation and patient interrogation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['arterial hypertension', 'elevated blood pressure', 'ambulatory blood pressure measurement', 'antihypertensive medication'], 'conditions': ['Hypertension', 'Blood Pressure, High']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to analyse the prevalence of new or uncontrolled arterial hypertension (AHT) after hospital discharge of medical in-patients with elevated blood pressure (BP) values during hospitalisation.\n\nThe main questions it aims to answer are:\n\n* Do elevated BP values during hospitalisation correspond to new or uncontrolled AHT after hospital discharge?\n* Is it safe to postpone adaption of antihypertensive treatment until after proper evaluation of AHT after hospital discharge?\n\nParticipants will either be treated according to their physicians' decision or antihypertensive treatment adaptions will be postponed until after hospital discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient hospitalized on the internal medicine ward for non-cardiovascular causes, i.e. patients hospitalized for conditions, which are not acutely worsened by uncontrolled AHT\n* Asymptomatic elevated BP values (defined as 140-180 mmHg systolic and/or 90-110 mmHg diastolic) on at least 2 occasions\n* Ability to understand study procedures and to provide written informed consent\n\nExclusion Criteria:\n\n* Hospitalization for any conditions which can be worsened by uncontrolled AHT:\n* Cerebrovascular events\n* Acute coronary syndrome\n* Acute or decompensated heart failure\n* Any condition preventing ABPM\n* Pregnant or lactating women\n* Failure to provide informed consent'}, 'identificationModule': {'nctId': 'NCT06132451', 'acronym': 'INDEBP', 'briefTitle': 'In-Hospital Detection of Elevated Blood Pressure', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'In-Hospital Detection of Elevated Blood Pressure (INDEBP): Prevalence of New or Uncontrolled Hypertension and Safety of Postponement of Antihypertensive Treatment Adaption in Medical In-patients', 'orgStudyIdInfo': {'id': 'INDEBP-prospective'}, 'secondaryIdInfos': [{'id': '2023-01566', 'type': 'OTHER', 'domain': 'EKNZ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual practice arm', 'description': "Patients will be treated according to their treating physicians' decision."}, {'type': 'OTHER', 'label': 'Postponement of treatment arm', 'description': 'Antihypertensive treatment adaptions will be postponed until after a 24h ambulatory blood pressure measurement (ABPM) 4 weeks after hospital discharge.', 'interventionNames': ['Other: Postponement of antihypertensive treatment']}], 'interventions': [{'name': 'Postponement of antihypertensive treatment', 'type': 'OTHER', 'description': 'Hypertensive blood pressure values in medical in-patients will not be treated during hospitalisation until confirmed by ABPM 4 weeks after hospital discharge', 'armGroupLabels': ['Postponement of treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Annina Vischer, M.D.', 'role': 'CONTACT', 'email': 'annina.vischer@usb.ch', 'phone': '+41612652525'}], 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'centralContacts': [{'name': 'Annina Vischer, M.D.', 'role': 'CONTACT', 'email': 'annina.vischer@usb.ch', 'phone': '+41612652525'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annina Vischer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Annina Vischer', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}