Cardiometabolic Prevention Clinic for Cardiovascular Disease

(DUKE PREVENT Trial)

Overseen By Sarah Burns, MSCR

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Advanced dementia, Hospice, ESRD, Cardiac transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special clinic, staffed by heart, kidney, diabetes, and liver specialists, can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. Participants will either continue their usual care or receive coordinated care at the Duke Cardiometabolic Prevention Clinic, a specialized healthcare service. The researchers aim to assess whether this new approach improves health outcomes, such as reducing hospital visits and enhancing medication use, over 12 months. This trial suits adults with a history of heart problems and type 2 diabetes who have experienced high blood pressure and cholesterol in the past three months. As an unphased trial, it offers a unique opportunity to explore innovative care strategies that could enhance health management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this clinic protocol is safe for patients with type 2 diabetes and heart disease?

Research shows that referring patients to the Duke Cardiometabolic Prevention Clinic is generally safe. This clinic helps individuals with type 2 diabetes and heart disease manage their health more effectively. Specialists for the heart, kidneys, diabetes, and liver collaborate to enhance heart and metabolic health.

Previous studies have demonstrated that coordinated care effectively controls blood pressure and cholesterol levels. Reports of major safety issues with this approach are absent. Instead, it often results in better health outcomes by ensuring patients receive appropriate medications and lifestyle guidance. Overall, this approach is well-tolerated and can potentially reduce hospital visits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Duke Cardiometabolic Prevention Clinic approach because it offers a personalized and coordinated care strategy for preventing cardiovascular disease. Unlike standard treatments, which typically involve routine check-ups with a primary care provider, this clinic involves a multidisciplinary team that evaluates and manages each patient's unique risk factors. This can include referrals to specialists in areas like endocrinology, nephrology, or hepatology, offering a more comprehensive management of heart and metabolic health. By focusing on a tailored prevention plan, the clinic aims to address the root causes of cardiometabolic issues more effectively.

What evidence suggests that the Duke Cardiometabolic Prevention Clinic is effective for managing type 2 diabetes and heart disease?

Research has shown that a team of doctors working together in a clinic can greatly improve health for people with type 2 diabetes and heart disease. In this trial, participants referred to the Duke Cardiometabolic Prevention Clinic will receive coordinated care from specialists, which may include heart and diabetes doctors. Studies have found that when such specialists collaborate, patients often have better control of their blood pressure and cholesterol. For example, one study found that patients who visited a heart specialist clinic had improved blood pressure and cholesterol levels over two years. These clinics help people manage their conditions through education, lifestyle changes, and medication management. Overall, this approach has been linked to more use of recommended heart medications and fewer hospital visits. ^{1 2 3 5 6}

Who Is on the Research Team?

Neha J Pagidipati, MD, MPH

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for people with type 2 diabetes and heart disease who struggle to control their blood pressure and cholesterol. Participants should not be currently receiving multidisciplinary care for these conditions.

Inclusion Criteria

Uncontrolled 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.

I have Type 2 Diabetes.

I am 18 years old or older.

Exclusion Criteria

History of advanced dementia

Lives outside of Durham County, Orange County, Wake County, Person County or Granville County

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Evaluation

Participants meet with a cardiologist for an initial evaluation and are referred to other specialists based on their needs

1-2 weeks

1 visit (in-person)

Treatment

Participants receive ongoing, coordinated care from a team of specialists to improve heart and metabolic health

12 months

Regular visits (in-person and virtual)

Follow-up

Participants are monitored for changes in LDL-C, systolic blood pressure, and healthcare utilization

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Referral to the Duke Cardiometabolic Prevention Clinic

Trial Overview The study tests if a specialized clinic with a team of heart, kidney, diabetes, and liver specialists can better manage cardiovascular risks compared to usual care from primary providers over a year.

How Is the Trial Designed?

Group I: Referral to Cardiometabolic Prevention Clinic Experimental Treatment 1 Intervention

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 II: Standard of Care Group Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Barnhill Family Foundation

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07117695

Duke Cardiometabolic Prevention Clinic's Impact on High- ... The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic ...

2. dukehealth.org dukehealth.org/locations/duke-cardiometabolic-prevention-south-durham

Duke Cardiometabolic Prevention South Durham We help people manage their disease risk factors through education, lifestyle changes, medication management, and referrals to other specialists as needed. Our ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/PMC12132730

Association of Cardiologist Clinic Visits With ... Primary outcomes were blood pressure control (<140/90 mm Hg) and lipid control (low-density lipoprotein cholesterol ≤100 mg/dL) over 2 years and ...

4. withpower.com withpower.com/trial/phase-hyperlipidemias-8-2025-d14c7

Cardiometabolic Prevention Clinic for Cardiovascular ... 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, ...

5. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-duke-cardiometabolic-prevention-clinic-s-impact-on-high-risk-cardiovascular-patients-with-uncontrolled-risk-factors/555748936

Duke Cardiometabolic Prevention Clinic's Impact on High- ... The study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke ...

6. scholars.duke.edu scholars.duke.edu/individual/pub1642302

Association of Cardiologist Clinic Visits with Cardiovascular ... Primary outcomes were blood pressure control (<140/90 mmHg) and lipid control (LDL-C ≤ 100 mg/dl) over 2 years and time to first major adverse ...