ASCVDDUKE PREVENTNCT07117695
Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors
A study testing Referral to the Duke Cardiometabolic Prevention Clinic in people with ASCVD and Hyperlipidemia, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASCVD, Hyperlipidemia, Hypertension
- What is being tested?
- Referral to the Duke Cardiometabolic Prevention Clinic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2026to 27 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
Sara Burns, MSCR, 910-272-7239, sarah.durden@duke.edu
About this study
Official title: Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients
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
- Being tested
- Referral to the Duke Cardiometabolic Prevention Clinic
- Keywords
- ASCVD, Cardiometabolic Clinic, Prevention, Hypertension, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral to the Duke Cardiometabolic Prevention ClinicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LDL-C
Change in low-density-lipoprotein cholesterol from baseline
Measured: Baseline, 12 months after enrollment
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline
Measured: Baseline, 12 months after enrollment
Secondary outcomes (2)
Number of participants meeting Risk Factor Targets
Those achieving both of the following, and of attaining each component individually: systolic blood pressure (sBP) < 130 and low-density-lipoprotein (LDL) < 70mg/dL
Measured: 12 months after enrollment
Change in Number of participants on Evidence-Based Medication Targets
Evidence-based medications include (where appropriate) ACE/ARB/ARNI, high-intensity statin, SGLT2i or GLP-1 RA.
Measured: Baseline, 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start2 Oct 2026 (estimated)
- Primary completion27 Oct 2027 (estimated)
- Study completion27 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASCVDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Barnhill Family Foundation
- Responsible party
- Sponsor
- Investigators
- Neha J Pagidipati, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117695
- Sponsor's protocol ID
- Pro00121119
- Acronym
- DUKE PREVENT
- Status last verified
- Sep 2026
- First submitted
- 5 Aug 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients
- ClinicalTrials.gov ID
- NCT07117695
- Acronym / sponsor ID
- DUKE PREVENT / Pro00121119
- Conditions
- ASCVD, Hyperlipidemia, Hypertension
- Keywords
- ASCVD, Cardiometabolic Clinic, Prevention, Hypertension, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Barnhill Family Foundation
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 27 Oct 2027 (estimated)
- Study completion
- 27 Feb 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral to Cardiometabolic Prevention Clinic | Experimental | Other: Referral to the Duke Cardiometabolic Prevention ClinicParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral to the Duke Cardiometabolic Prevention ClinicPatients 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. | Other | Referral to Cardiometabolic Prevention Clinic |
Primary outcome
Change in LDL-C
Time frame: Baseline, 12 months after enrollment
Change in low-density-lipoprotein cholesterol from baseline
Change in Systolic Blood Pressure
Time frame: Baseline, 12 months after enrollment
Change in systolic blood pressure from baseline
2 secondary outcomes
Number of participants meeting Risk Factor Targets
Time frame: 12 months after enrollment
Change in Number of participants on Evidence-Based Medication Targets
Time frame: Baseline, 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha J Pagidipati, MD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral to the Duke Cardiometabolic Prevention Clinic in people with ASCVD and Hyperlipidemia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Burns, MSCR (910-272-7239, sarah.durden@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LDL-C (time frame: Baseline, 12 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.