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NCT Number: NCT07117695

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

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.

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Key information

Conditions

ASCVD Cardiovascular Diseases Dyslipidemias Hyperlipidemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location contact

Sara Burns, MSCR

CONTACT

[email protected]

910-272-7239

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in LDL-C

    Time frame: Baseline, 12 months after enrollment

    Change in low-density-lipoprotein cholesterol from baseline

  2. Change in Systolic Blood Pressure

    Time frame: Baseline, 12 months after enrollment

    Change in systolic blood pressure from baseline

Secondary outcomes

  1. Number of participants meeting Risk Factor Targets

    Time frame: 12 months after enrollment

    Those achieving both of the following, and of attaining each component individually: systolic blood pressure (sBP) < 130 and low-density-lipoprotein (LDL) < 70mg/dL

  2. Change in Number of participants on Evidence-Based Medication Targets

    Time frame: Baseline, 12 months after enrollment

    Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA.

Other outcomes

  1. Time to first composite event of all-cause mortality, myocardial infarction, stroke, or coronary revascularization

    Time frame: 12 months after enrollment

  2. Healthcare Utilization: Outpatient Encounters

    Time frame: 12 months after enrollment

    Number of outpatient encounters

  3. Healthcare Utilization: All-cause hospitalizations

    Time frame: 12 months after enrollment

    Number of all-cause hospitalizations

  4. Healthcare Utilization: Number of cardiovascular (CV) hospitalizations

    Time frame: 12 months after enrollment

    CV hospitalizations include those for MI (myocardial infarction), HF (heart failure), stroke, coronary or peripheral revascularization/amputation.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Burns, MSCR

CONTACT

[email protected]

910-272-7239

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Barnhill Family Foundation

Registry information

Official study title

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

Acronym: DUKE PREVENT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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