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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether team care at the Duke Cardiometabolic Prevention Clinic helps adults with type 2 diabetes, heart or blood vessel disease, and high blood pressure and cholesterol. Patients are randomly assigned to usual care or the specialty clinic. Over 12 months, the study will compare blood pressure, cholesterol, heart medicine use, and hospital visits and other health care use.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 18 or older.
  • You have a history of heart or blood vessel disease, such as a heart attack, stroke from a blocked artery, or a procedure to restore blood flow in an artery.
  • You have type 2 diabetes.
  • In the past 3 months, your top blood pressure number was over 150 mmHg at least once AND your LDL (“bad”) cholesterol was over 130 mg/dL.
  • If not enough patients qualify, the study may accept these blood pressure and cholesterol results from the past 6 months.

Who can't join

  • You now receive or previously received care from providers at the Duke Cardiometabolic Prevention Clinic.
  • You have a history of advanced dementia, which causes severe problems with memory and thinking.
  • You have been referred to hospice or receive hospice care, which supports people near the end of life.
  • You live outside Durham, Orange, Wake, Person, or Granville County.
  • You have severe kidney failure: you are on dialysis, a treatment that filters the blood, or your eGFR kidney function score is below 20.
  • You have had a heart transplant, are on the heart transplant waiting list, or receive care from the Advanced Heart Failure team.
  • You are pregnant or plan to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NC