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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Adults ≥ 18 years of age
  2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)
  3. Type 2 Diabetes
  4. Uncontrolled sBP AND LDL-C within the preceding 3 months:
    • SBP > 150mmHg on at least 1 occasion in last 3 months, AND
    • LDL > 130mg/dL in last 3 months
      • 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.

Exclusion Criteria:

  1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)
  2. History of advanced dementia
  3. Referred to hospice/on hospice
  4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County
  5. End Stage Renal Disease (those on dialysis or with EGFR <20)
  6. History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure
  7. Pregnant/Planning to become pregnant during study period

Study details
    ASCVD
    Hyperlipidemia
    Hypertension

NCT07117695

Duke University

21 October 2025

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