Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT01734135
Status:
COMPLETED
Last Update Posted:
2025-09-19
First Post:
2012-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Provider Notification for High B-type Natriuretic Peptide Values
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2012-11-20', 'studyFirstSubmitQcDate': '2012-11-20', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of left ventricular ejection fraction', 'timeFrame': '6 months after randomization', 'description': 'numerator: Measurement of left ventricular ejection fraction within 6 months of randomization.\n\ndenominator: All randomized patients'}], 'secondaryOutcomes': [{'measure': 'Identification of LVEF < 40%', 'timeFrame': '6 months following randomizaiton', 'description': 'Numerator: number of patients identified with an LVEF\\< 40% Denominator: all randomized patients'}, {'measure': 'Treatment of Low LVEF', 'timeFrame': '6 months following randomization', 'description': 'Numerator: number of patients with an LVEF \\< 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol).\n\nDenominator: all randomized patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['B type natriuretic peptide', 'heart failure', 'cardiac imaging', 'quality of care'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging.\n\nElectrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.', 'detailedDescription': 'Rationale: B type natriuretic peptide is known to be elevated (\\> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is \\< 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection.\n\nHypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BNP \\>= 200 pg/ml in last 2 months\n\nExclusion Criteria:\n\n* Measure of LVEF in the last 12 months\n* Last measure of LVEF \\< 40%'}, 'identificationModule': {'nctId': 'NCT01734135', 'briefTitle': 'Provider Notification for High B-type Natriuretic Peptide Values', 'organization': {'class': 'FED', 'fullName': 'VA Palo Alto Health Care System'}, 'officialTitle': 'Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.', 'orgStudyIdInfo': {'id': 'CHFQUERI-1101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Usual care'}, {'type': 'EXPERIMENTAL', 'label': 'Clinical Reminder', 'description': 'A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.', 'interventionNames': ['Other: Clinical Reminder']}], 'interventions': [{'name': 'Clinical Reminder', 'type': 'OTHER', 'description': 'A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.', 'armGroupLabels': ['Clinical Reminder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Paul A Heidenreich, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Palo Alto HCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Palo Alto Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Paul Heidenreich', 'investigatorAffiliation': 'VA Palo Alto Health Care System'}}}}