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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

RecruitingNAAges 18 Years - anyAllOdense University Hospital
NCT07878325 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Cardio-Metabolic Clinic
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Where

1 site
Cardiovascular Research Unit at Odense University Hospital, Svendborg, Denmark.
Svendborg, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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