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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 • ClinicalTrials.gov ID: NCT07878325

Registry updated: 2026-10-16

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Description

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

Interventions

Cardio-Metabolic Clinic (Other)
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

Eligibility criteria

Inclusion Criteria: 1. \> 18 years of age 2. Capable of giving written informed consent. 3. Established diagnosis of Type 2 diabetes. 4. Established heart or vascular disease, defined as either: 4a. Atherosclerotic disease defined as one of the following: I. Prior acute coronary syndrome, defined according to ESC guidelines. II. Chronic coronary syndrome defined according to ESC guidelines: a) Angina pectoris AND b) Signs of coronary atherosclerosis assessed with either coronary CT angiography (CTA) or myocardial-scintigraphy (MPI) or coronary angiography (CAG) AND c) treatment with statins and/or acetylsalicylic acid. III. Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: \>10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium-score \>100. IV. Non coronary vascular disease defined as: 1. Prior stroke 2. Peripheral arterial disease (PAD) PAD is defined as: Claudication intermittence AND pathological ankle brachial index (ABI) AND/OR vascular PAD surgery AND/OR ischemic amputation 4b. Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease defined according to ESC guidelines. 4c. Clinically significant valvular heart disease (which requires control in outpatient clinic of cardiology), such as: Aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation. 4d. Hypertension treated with a minimum of three antihypertensive drugs. 4e. Heart failure with preserved ejection fraction (HFpEF) Exclusion Criteria: 1. Life expectancy less than 5 years for any reason. 2. Type 1 Diabetes Mellitus (26). 3. Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this or the ProtecT-2D parent study. 4. Patients with a history of chronic heart failure: HFrEF, HFmrEF.

Conditions

Cardiovascular Disease Cardiometabolic Diseases Diabetes Type 2 Diabetes and Heart Failure Heart Failure With Preserved Ejection Fraction (HFpEF Diabetes Complication

Locations

Cardiovascular Research Unit at Odense University Hospital, Svendborg, Denmark. — Svendborg, Denmark

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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