Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07117695
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Referral to the Duke Cardiometabolic Prevention Clinic — OTHER
    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.

Study Details

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. The 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. Participants 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.

Key Dates

Start date
Jun 2, 2026
Status verified
Aug 2025
Primary completion
Sep 27, 2027
Completion
Dec 27, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Referral to Cardiometabolic Prevention Clinic
    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.
  • No Intervention: Standard of Care Group
    Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.

Primary Outcome Measure

Change in LDL-C [ Time Frame: Baseline, 12 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710
Sara Burns, MSCR
910-272-7239

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