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

NCT07117695 | Not Yet Recruiting DMC

• 1 other identifier: Pro00109610
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

ASCVD; Cardiometabolic Clinic; Prevention; Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (2)

• Change in LDL-C

  Change in low-density-lipoprotein cholesterol from baseline

  Baseline, 12 months after enrollment

• Change in Systolic Blood Pressure

  Change in systolic blood pressure from baseline

  Baseline, 12 months after enrollment

Secondary Outcomes (2)

• Number of participants meeting Risk Factor Targets

  12 months after enrollment

• Change in Number of participants on Evidence-Based Medication Targets

  Baseline, 12 months after enrollment

Other Outcomes (4)

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

  12 months after enrollment

• Healthcare Utilization: Outpatient Encounters

  12 months after enrollment

• Healthcare Utilization: All-cause hospitalizations

  12 months after enrollment

Study Arms (2)

Referral to Cardiometabolic Prevention Clinic

EXPERIMENTAL

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.

Other: Referral to the Duke Cardiometabolic Prevention Clinic

Standard of Care Group

NO INTERVENTION

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

Interventions

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.

Referral to Cardiometabolic Prevention Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Barnhill Family Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Hyperlipidemias; Hypertension

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Neha J Pagidipati, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Burns, MSCR

CONTACT

910-272-7239; sarah.durden@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start (Estimated): June 2, 2026
• Primary Completion (Estimated): September 27, 2027
• Study Completion (Estimated): December 27, 2027
• Last Updated: February 24, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)