Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT05858320
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2023-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-25', 'studyFirstSubmitDate': '2023-05-01', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint: Change in GDMT medication score', 'timeFrame': 'Baseline to Week 12', 'description': 'Change in GDMT medication score generated by the computable algorithm from baseline to Week 12'}], 'secondaryOutcomes': [{'measure': 'Secondary Endpoint: Level of agreement between the medication optimization algorithm recommendations and actual GDMT prescribed', 'timeFrame': 'Over 12 Weeks', 'description': 'The level of agreement between the medication optimization algorithm recommendations (Yes/No) and actual GDMT prescribed (Yes/No)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '38939592', 'type': 'BACKGROUND', 'citation': 'Dorsch MP, Sifuentes A, Cordwin DJ, Kuo R, Rowell BE, Arzac JJ, DeBacker K, Guidi JL, Hummel SL, Koelling TM. A Computable Algorithm for Medication Optimization in Heart Failure With Reduced Ejection Fraction. JACC Adv. 2023 Apr 12;2(3):100289. doi: 10.1016/j.jacadv.2023.100289. eCollection 2023 May.'}]}, 'descriptionModule': {'briefSummary': 'The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site.\n\nThe intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.', 'detailedDescription': 'The investigators have developed an adaptive medication optimization web application, named SmartHF, that provides patients with tailored information about potential HFrEF GDMT optimization. SmartHF guides patients to share the GDMT optimization recommendations with their provider during a clinic visit.\n\nParticipants will be randomized to receive the web application intervention or control up to 30 days before a clinic visit in a 1:1 manner and followed for 12 weeks after the clinic visit. This trial will determine the efficacy of SmartHF in prescribing GDMT in HFrEF patients compared to controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 years and older at screening\n2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) \\</= 40% (HFrEF)\n3. Have a general medicine provider or general cardiology provider for HFrEF\n4. Have internet access and access to their health system's patient portal\n5. Fluent in spoken and written English\n6. At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70\n7. At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose\n\nExclusion Criteria:\n\n1. End-stage HF (hospice candidate)\n2. Actively treated cancer, except non-melanoma skin cancer\n3. Implanted ventricular assist device\n4. Current treatment with chronic inotropic therapy\n5. Patient's provider for HFrEF care is considered an advanced HF specialist\n6. Currently pregnant or intends to become pregnant during the study period\n7. Dialysis"}, 'identificationModule': {'nctId': 'NCT05858320', 'acronym': 'SmartHF', 'briefTitle': 'The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)', 'orgStudyIdInfo': {'id': 'HUM00227631'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SmartHF application', 'description': 'The web application-based study intervention provides adaptive medication recommendations that can be shared with their HF provider.', 'interventionNames': ['Other: SmartHF application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Patients Standard Medication(s)', 'description': 'No change to current medication(s)', 'interventionNames': ['Other: SmartHF application']}], 'interventions': [{'name': 'SmartHF application', 'type': 'OTHER', 'description': 'Adaptive medication recommendations that can be shared with the participants HF provider.', 'armGroupLabels': ['Control - Patients Standard Medication(s)', 'SmartHF application']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University, Grady Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital and Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48197', 'city': 'Ypsilanti', 'state': 'Michigan', 'country': 'United States', 'facility': 'Trinity Healthcare St. Joseph Mercy Ann Arbor', 'geoPoint': {'lat': 42.24115, 'lon': -83.61299}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University, Barns Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Washington University, Barns Jewish Hospital, St. Louis, MO', 'class': 'UNKNOWN'}, {'name': 'Henry Ford Hospital, Detroit, MI', 'class': 'UNKNOWN'}, {'name': 'Emory University, Grady Hospital, Atlanta, GA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pharmacy, College of Pharmacy and Clinical Pharmacist, University of Michigan Inpatient Pharmacy Services', 'investigatorFullName': 'Michael Dorsch', 'investigatorAffiliation': 'University of Michigan'}}}}