Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-01-07 @ 6:13 AM
Study NCT ID:
NCT07117695
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2025-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-06-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-16', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to first composite event of all-cause mortality, myocardial infarction, stroke, or coronary revascularization', 'timeFrame': '12 months after enrollment'}, {'measure': 'Healthcare Utilization: Outpatient Encounters', 'timeFrame': '12 months after enrollment', 'description': 'Number of outpatient encounters'}, {'measure': 'Healthcare Utilization: All-cause hospitalizations', 'timeFrame': '12 months after enrollment', 'description': 'Number of all-cause hospitalizations'}, {'measure': 'Healthcare Utilization: Number of cardiovascular (CV) hospitalizations', 'timeFrame': '12 months after enrollment', 'description': 'CV hospitalizations include those for MI (myocardial infarction), HF (heart failure), stroke, coronary or peripheral revascularization/amputation.'}], 'primaryOutcomes': [{'measure': 'Change in LDL-C', 'timeFrame': 'Baseline, 12 months after enrollment', 'description': 'Change in low-density-lipoprotein cholesterol from baseline'}, {'measure': 'Change in Systolic Blood Pressure', 'timeFrame': 'Baseline, 12 months after enrollment', 'description': 'Change in systolic blood pressure from baseline'}], 'secondaryOutcomes': [{'measure': 'Number of participants meeting Risk Factor Targets', 'timeFrame': '12 months after enrollment', 'description': 'Those achieving both of the following, and of attaining each component individually: systolic blood pressure (sBP) \\< 130 and low-density-lipoprotein (LDL) \\< 70mg/dL'}, {'measure': 'Change in Number of participants on Evidence-Based Medication Targets', 'timeFrame': 'Baseline, 12 months after enrollment', 'description': 'Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASCVD', 'Cardiometabolic Clinic', 'Prevention', 'Hypertension', 'Hyperlipidemia'], 'conditions': ['ASCVD', 'Hyperlipidemia', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'This project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors.\n\nThe study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use.\n\nParticipants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 18 years of age\n2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)\n3. Type 2 Diabetes\n4. Uncontrolled sBP AND LDL-C within the preceding 3 months:\n\n * SBP \\> 150mmHg on at least 1 occasion in last 3 months, AND\n * LDL \\> 130mg/dL in last 3 months\n\n * NOTE: If there are not enough patients with the above inclusion criteria available for enrollment, then we will expand the criteria to include patients with uncontrolled sBP and LDL-C within the last 6 months.\n\nExclusion Criteria:\n\n1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)\n2. History of advanced dementia\n3. Referred to hospice/on hospice\n4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County\n5. End Stage Renal Disease (those on dialysis or with EGFR \\<20)\n6. History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure\n7. Pregnant/Planning to become pregnant during study period'}, 'identificationModule': {'nctId': 'NCT07117695', 'acronym': 'DUKE PREVENT', 'briefTitle': "Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors", 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients', 'orgStudyIdInfo': {'id': 'Pro00109610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Referral to Cardiometabolic Prevention Clinic', 'description': 'Participants referred to the Duke Cardiometabolic Prevention Clinic will be evaluated by a cardiology provider and receive coordinated care based on their risk factors. This may include referrals to specialists in endocrinology, nephrology, or hepatology. A multidisciplinary team will manage their care to help improve heart and metabolic health.', 'interventionNames': ['Other: Referral to the Duke Cardiometabolic Prevention Clinic']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of Care Group', 'description': 'Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.'}], 'interventions': [{'name': 'Referral to the Duke Cardiometabolic Prevention Clinic', 'type': 'OTHER', 'description': "Patients who are referred to the cardiometabolic prevention clinic within the intervention arm will be evaluated first by a cardiology provider (as each patient has a history of ASCVD). On this initial visit, the cardiology provider will assess the patient's risk factor profile - to identify the presence of co-morbid conditions or uncontrolled risk factors. The need for additional referrals to other clinicians within the cardiometabolic clinic will specifically outlined criteria. These referrals will be offered to the patient and facilitated after the first visit. Preventive care will follow routine, evidence-based care. Clinicians within the cardiometabolic prevention clinic will meet bi-weekly to discuss enrolled patients, thus every individual in the intervention arm will receive coordinated, multi-specialty care.", 'armGroupLabels': ['Referral to Cardiometabolic Prevention Clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Burns, MSCR', 'role': 'CONTACT', 'email': 'sarah.durden@duke.edu', 'phone': '910-272-7239'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Sarah Burns, MSCR', 'role': 'CONTACT', 'email': 'sarah.durden@duke.edu', 'phone': '910-272-7239'}], 'overallOfficials': [{'name': 'Neha J Pagidipati, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Barnhill Family Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}