Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-13 @ 3:50 PM
Study NCT ID:
NCT00661895
Status:
COMPLETED
Last Update Posted:
2012-12-04
First Post:
2007-12-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Black Education and Treatment of Hypertension (BEAT HTN)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D017706', 'term': 'Lisinopril'}, {'id': 'C091365', 'term': 'hydrochlorothiazide, lisinopril drug combination'}, {'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D008790', 'term': 'Metoprolol'}, {'id': 'D001262', 'term': 'Atenolol'}, {'id': 'D000068756', 'term': 'Valsartan'}, {'id': 'D017292', 'term': 'Doxazosin'}, {'id': 'D003000', 'term': 'Clonidine'}, {'id': 'D006830', 'term': 'Hydralazine'}, {'id': 'D017311', 'term': 'Amlodipine'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004151', 'term': 'Dipeptides'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D014633', 'term': 'Valine'}, {'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D011224', 'term': 'Prazosin'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D010793', 'term': 'Phthalazines'}, {'id': 'D011724', 'term': 'Pyridazines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TammyBurns@creighton.edu', 'phone': '402-280-4292', 'title': 'Tammy Burns, PharmD, Research Manager', 'organization': 'Creighton Cardiac Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).', 'otherNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'No intervention', 'otherNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving Blood Pressure Goals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Free antihypertensive medications, basic hypertension education and usual clinical care.'}], 'classes': [{'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 month intervals', 'description': 'Percentage of subjects who achieved JNC-VII defined blood pressure goals.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'New Onset Diabetes Mellitus', 'timeFrame': '3 month intervals', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).'}, {'id': 'FG001', 'title': 'Control', 'description': 'No intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).'}, {'id': 'BG001', 'title': 'Control', 'description': 'No intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.6', 'spread': '9.81', 'groupId': 'BG000'}, {'value': '50', 'spread': '11', 'groupId': 'BG001'}, {'value': '49.8', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2007-12-28', 'resultsFirstSubmitDate': '2011-08-04', 'studyFirstSubmitQcDate': '2008-04-17', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-06', 'studyFirstPostDateStruct': {'date': '2008-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving Blood Pressure Goals', 'timeFrame': '3 month intervals', 'description': 'Percentage of subjects who achieved JNC-VII defined blood pressure goals.'}], 'secondaryOutcomes': [{'measure': 'New Onset Diabetes Mellitus', 'timeFrame': '3 month intervals'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['African American'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. Because of this, it has not yet been determined whether the method of prescribing antihypertensive medications according to JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive medications and providing intensive behavioral and clinical interventions. Knowledge in this area of HTN treatment should better able medical and health practitioners to help their AA subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control by proposing a program that will evaluate the difference in HTN control among subjects receiving usual care and free medications and subjects also receiving free medications, but additionally being treated in a clinic that operates in a more intensive manner in relationship to patient behavior modification, patient-clinician interactions, and physical and social environments. At the conclusion of the study, the BEAT Hypertension Clinic investigators will report findings and help to answer the question of whether medication alone or medication combined with intensive behavioral and clinical treatment is more effective in HTN control in the AA population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area\n2. History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines\n3. Study eligibility will be based on the subject's current blood pressure control based on the average of two seated blood pressure measurements at two consecutive clinic visits at least one week apart\n\n 1. Untreated subjects with elevated blood pressure (\\> 140/90 mmHg or \\< 130/80 mmHg for diabetics)\n 2. Subjects treated with antihypertensive therapy whose blood pressure does not meet current JNC 7 guidelines (\\< 140/90 mmHg for non-diabetics and \\< 130/80 mmHg for diabetics)\n\nExclusion Criteria:\n\n1. Myocardial infarction or stroke in the previous 6 months\n2. Symptomatic heart failure or a left ventricular ejection fraction \\< 35%\n3. Angina pectoris in the prior six months\n4. Coronary revascularization procedure in the prior 6 months\n5. Renal insufficiency defined as a serum creatinine \\> 2 mg/dl\n6. Illicit drug or alcohol abuse in the prior 6 months\n7. Dementia or other organic brain disease\n8. Serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial\n9. Secondary HTN\n10. Concurrent participation in an investigational medication trial"}, 'identificationModule': {'nctId': 'NCT00661895', 'acronym': 'BEAT', 'briefTitle': 'Black Education and Treatment of Hypertension (BEAT HTN)', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Black Education and Treatment of Hypertension (BEAT HTN)', 'orgStudyIdInfo': {'id': '05-13859'}, 'secondaryIdInfos': [{'id': '05-13589', 'type': 'OTHER', 'domain': 'Creighton University Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).', 'interventionNames': ['Drug: Hydrochlorothiazide', 'Drug: Lisinopril', 'Drug: Lisinopril and Hydrochlorothiazide', 'Drug: Nifedipine XL', 'Drug: Metoprolol tartrate', 'Drug: Atenolol', 'Drug: Valsartan', 'Drug: Doxazosin', 'Drug: Clonidine', 'Drug: Hydralazine', 'Drug: Metoprolol succinate', 'Drug: Amlodipine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'No intervention', 'interventionNames': ['Drug: Hydrochlorothiazide', 'Drug: Lisinopril', 'Drug: Lisinopril and Hydrochlorothiazide', 'Drug: Nifedipine XL', 'Drug: Metoprolol tartrate', 'Drug: Atenolol', 'Drug: Valsartan', 'Drug: Doxazosin', 'Drug: Clonidine', 'Drug: Hydralazine', 'Drug: Metoprolol succinate', 'Drug: Amlodipine']}], 'interventions': [{'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': 'Hydrochlorothiazide 25 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Lisinopril', 'type': 'DRUG', 'description': 'Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Lisinopril and Hydrochlorothiazide', 'type': 'DRUG', 'description': 'L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Nifedipine XL', 'type': 'DRUG', 'description': '30 mg extended release tablets, 60 mg extended release tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Metoprolol tartrate', 'type': 'DRUG', 'otherNames': ['Lopressor'], 'description': '50 mg tablets \\& 100 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Atenolol', 'type': 'DRUG', 'description': '50 mg tablet', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Valsartan', 'type': 'DRUG', 'description': '80 mg tablets \\& 160 mg tablet', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Doxazosin', 'type': 'DRUG', 'description': '4 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Clonidine', 'type': 'DRUG', 'description': '0.2 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Hydralazine', 'type': 'DRUG', 'description': '50 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Metoprolol succinate', 'type': 'DRUG', 'otherNames': ['Toprol XL'], 'description': '50 mg tablet \\& 100 mg tablet', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Amlodipine', 'type': 'DRUG', 'otherNames': ['Norvasc'], 'description': '5 mg tablets \\& 10 mg tablets', 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68104', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton Community Health Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Syed Mohiuddin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}