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Effects of a Specialized Diabetes and Heart Clinic and Detection of Unrecognized Heart Failure in People With Type 2 Diabetes and Cardiovascular Disease
Sponsor: Odense University Hospital
Summary
The goal of this clinical trial is to investigate the effects of a specialized Cardio-Metabolic Clinic (CMC) in people with type 2 diabetes and established cardiovascular disease. The CMC provides integrated and individualized diabetes and cardiovascular care aimed at optimizing medication, lifestyle, and management of related health conditions. Treatment recommendations are supported by a decision-support algorithm combining individual patient information with current clinical guidelines. Echo-CT-ProtecT-2D comprises two parallel studies conducted within the same randomized study population: Study 1 - EchoProtecT-2D focuses on cardiac function and heart failure phenotyping. The main questions are: * Can treatment in the CMC improve heart function at rest and during physical activity compared with usual care? * Can treatment in the CMC reduce systemic inflammation and improve physical function, symptoms, and quality of life? * How common is previously unrecognized heart failure, particularly heart failure with preserved ejection fraction (HFpEF), in this high-risk population? Study 2 - CT-ProtecT-2D focuses on coronary inflammation and atherosclerosis. The main questions are: * Can treatment in the CMC reduce inflammation around the coronary arteries compared with usual care? * Can treatment in the CMC reduce the burden of coronary atherosclerosis compared with usual care? * Can treatment in the CMC lead to favorable changes in the composition and high-risk features of coronary atherosclerotic plaques compared with usual care? Participants will be randomly assigned to either treatment in the CMC or usual care provided by their regular healthcare providers. Participants will: * Have an ultrasound examination of the heart (echocardiography) at rest and during physical activity at baseline and after 12 months * Have a CT scan of the coronary arteries at baseline and after 12 months * Provide blood and urine samples * Complete questionnaires about symptoms and quality of life * Complete a six-minute walk test to assess physical function * If assigned to the CMC, attend additional clinic visits as needed to optimize treatment
Official title: Echo-CT-ProtecT-2-D: Effects of an Integrated Multifactorial Cardiometabolic Intervention and Identification of Unrecognized HFpEF in Patients With Type 2 Diabetes and Established Cardiovascular Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
375
Start Date
2026-10-20
Completion Date
2027-12-01
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
Cardio-Metabolic Clinic
Multifactorial management of T2D and cardiovascular disease, including comprehensive assessment of macro- and microvascular complications and individualized treatment optimization according to current clinical guidelines and recommendations. Treatment optimization is supported by an algorithm integrating individual patient data with guideline-based recommendations. The assessment will encompass the following treatment areas: * Lipid management * Blood pressure management * Antithrombotic therapy * Glycemic targets * Prevention of diabetes-related complications * Treatment of vascular disease affecting the lower extremities * Evaluation of cardioprotective drugs * Counseling on lifestyle factors, including diet, smoking, alcohol, and exercise * Guidance on vaccinations
Locations (1)
Cardiovascular Research Unit at Odense University Hospital, Svendborg, Denmark.
Svendborg, Denmark