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

NCT ID: NCT07117695

Last Updated: 2026-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-06-02
• Study Completion Date: 2027-12-27

Brief Summary

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.

Conditions

ASCVD; Hyperlipidemia; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Referral to Cardiometabolic Prevention Clinic

Participants referred to the Duke Cardiometabolic Prevention Clinic will be evaluated by a cardiology provider and receive coordinated care based on their risk factors. This may include referrals to specialists in endocrinology, nephrology, or hepatology. A multidisciplinary team will manage their care to help improve heart and metabolic health.

Group Type: EXPERIMENTAL

Referral to the Duke Cardiometabolic Prevention Clinic

Intervention Type: 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.

Standard of Care Group

Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Referral to the Duke Cardiometabolic Prevention Clinic

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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnhill Family Foundation

UNKNOWN

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neha J Pagidipati, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Burns, MSCR

Role: CONTACT

sarah.durden@duke.edu

910-272-7239

Facility Contacts

Sara Burns, MSCR

Role: primary

sarah.durden@duke.edu

910-272-7239

Other Identifiers

Pro00109610

Identifier Type: -

Identifier Source: org_study_id