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Transform CV Risk in Diabetes

Transform CV Risk in Diabetes

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05948969
Acronym
CVRiD
Enrollment
750
Registered
2023-07-17
Start date
2023-09-01
Completion date
2024-12-31
Last updated
2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Brief summary

This initiative supports a real-world study of practice and physician prescribing patterns and a quality improvement initiative evaluating best practices (including clinical decision support, facilitated referral to cardiometabolic team-based care model, and general educational tools/resources) to im-prove use of guideline-directed therapeutics known to lower cardiovascular risk (CV) in patients with type 2 diabetes (T2D).

Interventions

This implementation strategy will include the clinician education of the previous arm and apply audit and feedback of prior care to inform recommendations for future care. These suggestions will encompass 5 different domains based on eligibility and potential opportunity for an SGLT2i, GLP-1RA, angiotensin converting enzyme inhibitors (ACEi)/angiotensin-receptor blockers (ARB), antiplatelet or antithrombotic therapy, and statin therapy. The incorporation of clinical decision support technology will be utilized to identify tailored opportunities for each CV risk reduction based on guideline recommendations for individual patients. Clinicians will be presented prompts with patient-specific recommendation(s) for further optimization of cardioprotective agents. These prompts will be conveyed by a Study Coordinator to responsible clinicians. The follow-up clinical prompts will be based on auditing of updated clinical parameters and medication use.

OTHERFacilitated referral to a cardiometabolic team-based center

Each site will have access to clinicians caring for patients in structured, multidisciplinary cardiometabolic centers. Clinicians caring for patients randomized to this intervention strategy will receive a facilitated referral via the EHR together). If the clinician approves the referral, the patient will be referred to this local team-based comprehensive risk factor management clinic. All patients randomized to this group will be considered in this group whether or not a visit to the cardiometabolic center is completed.

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
American College of Cardiology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* T2D diagnosis in the medical record * ASCVD, defined as follows: 1. Known Coronary artery disease (CAD), prior Acute coronary syndrome (ACS), or coronary artery revascularization 2. Prior TIA/ischemic stroke or known carotid or intracerebral atherosclerosis, or prior carotid revascularization 3. Prior Peripheral artery disease (PAD) including symptomatic claudication or pe-ripheral revascularization

Exclusion criteria

* Current participation in an interventional clinical assessment of an investigational drug/device (excluding assessments related to COVID-19) * Currently receiving any SGLT2i or GLP-1RA * Known allergy/hypersensitivity/intolerance/contraindication to SGLT2i or GLP-1RA * Currently receiving comfort care or enrolled in hospice * Life expectancy \<1 year * History of or plan for heart transplantation or ventricular assist device * Current or planned hemodialysis * Decompensated end stage liver disease * History of Fournier's Gangrene * Type 1 diabetes * Prior history of diabetic ketoacidosis * Pregnancy or active breastfeeding * History of Pancreatitis or pancreatic cancer * History of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Design outcomes

Primary

MeasureTime frameDescription
New prescription of a SGLT2i and/or GLP-1RA9 monthsProportion of treatment-naïve patients who are newly prescribed a SGLT2i and/or GLP-1RA over 9 months in the facilitated referral group (Arm C) versus usual care group (Arm A)

Countries

United States

Contacts

Primary ContactShilpa Patel
SPatel@acc.org2023756354
Backup ContactJack Reilly
JReilly@acc.org202

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026