An interventional study of Referral to the Duke Cardiometabolic Prevention Clinic in ASCVD, Hyperlipidemia and Hypertension, sponsored by Duke University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Duke University · Not applicable, Interventional, and Health services research
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.
861 studies on the registry are indexed under Hyperlipidemias; 110 are open to participants now.
This study's planned enrollment of 150 is above the median of 88 across 735 interventional studies indexed under Hyperlipidemias.
Browse Hyperlipidemias studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Uncontrolled sBP AND LDL-C within the preceding 3 months:
LDL > 130mg/dL in last 3 months
Exclusion Criteria:
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
Participants in the standard care group will not be contacted directly and will continue their usual care with their primary care provider.
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.
Change in LDL-C
Change in low-density-lipoprotein cholesterol from baseline
Time frame: Baseline, 12 months after enrollment
Change in Systolic Blood Pressure
Change in systolic blood pressure from baseline
Time frame: Baseline, 12 months after enrollment
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
Time frame: 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.
Time frame: Baseline, 12 months after enrollment
Time to first composite event of all-cause mortality, myocardial infarction, stroke, or coronary revascularization
Time frame: 12 months after enrollment
Healthcare Utilization: Outpatient Encounters
Number of outpatient encounters
Time frame: 12 months after enrollment
Healthcare Utilization: All-cause hospitalizations
Number of all-cause hospitalizations
Time frame: 12 months after enrollment
Healthcare Utilization: Number of cardiovascular (CV) hospitalizations
CV hospitalizations include those for MI (myocardial infarction), HF (heart failure), stroke, coronary or peripheral revascularization/amputation.
Time frame: 12 months after enrollment
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2027, 12 months later.
Of 166 non-industry interventional studies with no phase under Hyperlipidemias, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 12 months is below that.
Counting every sponsor, half of 171 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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