๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-04

Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors (NCT07117695)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: Duke University

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).

Location: Duke University Medical Center โ€” Durham, North Carolina

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

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

๐Ÿ” Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Duke University Medical Center โ€” Durham, North Carolina

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—