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NCT07117695Not yet recruiting

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

Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
150 (estimated)
First submitted
5 Aug 2025
Start date
2 Oct 2026
Primary completion date
27 Oct 2027
Lead sponsor
Duke University
NCT number
NCT07117695

What you commit to

  • Study type: Interventional
  • Planned participants: 150
  • From 2 Oct 2026 to the primary completion date, 27 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)

Other illness

  • History of advanced dementia
  • History of cardiac transplant/Listed for Cardiac Transplant/Followed by Advanced Heart Failure

Lab values

  • End Stage Renal Disease (those on dialysis or with EGFR \<20)

Other

  • Referred to hospice/on hospice
  • Lives outside of Durham County, Orange County, Wake County, Person County or Granville County
  • Pregnant/Planning to become pregnant during study period

Who the study is looking for

  • Adults ≥ 18 years of age
  • Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)
  • Type 2 Diabetes
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Duke University Medical Center
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.