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Not yet recruiting NCT07117695

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

No phase Interventional ASCVD Hyperlipidemia Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Referral to the Duke Cardiometabolic Prevention Clinic.
Who it may be relevant to
Registry conditions: ASCVD, Hyperlipidemia, Hypertension. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Change in LDL-C [Time frame: Baseline, 12 months after enrollment]
  • Change in Systolic Blood Pressure [Time frame: Baseline, 12 months after enrollment]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Duke University Medical Center — Durham

Identifiers

NCT: NCT07117695 · Pro00109610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗