Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT06593327
Status:
RECRUITING
Last Update Posted:
2025-02-27
First Post:
2024-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients with Type 2 Diabetes: STRONG-DM Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D058065', 'term': 'Diabetic Cardiomyopathies'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2024-09-09', 'studyFirstSubmitQcDate': '2024-09-09', 'lastUpdatePostDateStruct': {'date': '2025-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incident Heart Failure or All-cause death', 'timeFrame': '2-year follow-up', 'description': 'Incident Heart Failure (based on electronic health record International Classification of Diseases codes) or all-cause death. This will be assessed via retrospective chart review.'}], 'secondaryOutcomes': [{'measure': 'Prescription Rates of SGLT2i', 'timeFrame': '6-months from electronic health record alert.', 'description': 'Counts of SGLT2 inhibitor prescriptions filled'}, {'measure': 'Prescription Rate of Finerenone', 'timeFrame': '6-months from electronic health record alert.', 'description': 'Counts of Finerenone prescriptions'}, {'measure': 'Prescription Rate of GLP1', 'timeFrame': '6-months from electronic health record alert.', 'description': 'Counts of GLP1 prescription'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pragmatic Clinical Trial', 'Heart Failure', 'Cardiovascular Prevention'], 'conditions': ['Type 2 Diabetes', 'Diabetic Cardiomyopathy', 'Heart Failure', 'Cardiometabolic Diseases']}, 'descriptionModule': {'briefSummary': 'A pragmatic, randomized clinical trial to evaluate the effect of a heart failure (HF) risk assessment and prevention strategy incorporating HF clinical risk scores (WATCH-DM) with cardiac biomarker (NT-proBNP) paired with a clinical decision support tool to implement an intensive prevention strategy among patients with high risk focused on implementation of evidence-based HF preventive therapies.', 'detailedDescription': 'Primary care providers will be randomized to receive notifications via the electronic health record if any patients with diabetes have high heart failure risk based on a combination of clinical risk scores(WATCH-DM), and biomarkers (NT-proBNP). Providers will be provided recommendation to initiate evidence based therapies (SGLT2 inhibitors, GLP1 agonists, non-steroidal MRA) , obtain expert e-consultation, or refer the patient to a cardiometabolic risk management program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary Care Provider that sees diabetes patients in clinic\n\nExclusion Criteria:\n\n* Provider does not see patients with Diabetes'}, 'identificationModule': {'nctId': 'NCT06593327', 'acronym': 'STRONG-DM', 'briefTitle': 'NT-ProBNP-based Heart Failure Screening and Prevention Trial in Patients with Type 2 Diabetes: STRONG-DM Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Evaluation of a Pragmatic NT-ProBNP-based Heart Failure Screening Strategy Among Patients with Type 2 Diabetes: STRONG-DM Study (Screening and Treatment Using Risk-based ApprOach with NT-ProBNP Guidance in Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'STU-2024-0458'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Risk Assessment and Intensive Prevention Strategy', 'description': 'Primary care providers (PCP) randomized to the Risk Assessment and Intensive Prevention Strategy Arm will receive notification if any patients with diabetes under their care have high heart failure risk based on clinical or biomarker scores. Providers will receive recommendations, option for e-consultation, and referral to cardiometabolic risk management program.', 'interventionNames': ['Behavioral: Intensive Prevention Strategy']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Primary care providers randomized to the Usual care arm will not receive any notifications about patients with diabetes and their HF risk assessment.'}], 'interventions': [{'name': 'Intensive Prevention Strategy', 'type': 'BEHAVIORAL', 'description': 'Providers randomized to the intensive prevention strategy will receive notification about patients with diabetes who have high heart failure risk and recommendations for medical management, e-consultation, or referral to a cardiometabolic risk management program.', 'armGroupLabels': ['Risk Assessment and Intensive Prevention Strategy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75209', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ambarish Pandey, MD', 'role': 'CONTACT', 'email': 'ambarish.pandey@utsouthwestern.edu', 'phone': '214-645-9868'}], 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Ambarish Pandey, MD', 'role': 'CONTACT', 'email': 'ambarish.pandey@utsouthwestern.edu', 'phone': '617-869-8957'}, {'name': 'VINAYAK SUBRAMANIAN, MD', 'role': 'CONTACT', 'phone': '2114-645-9868'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Diagnostics GmbH', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Ambarish Pandey', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}