Status:
RECRUITING
The Cardio-Metabolic Clinic
Lead Sponsor:
Odense University Hospital
Conditions:
Diabetes Mellitus, Type 2
Cardiovascular Diseases
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
This study aims to investigate whether a Cardio-Metabolic Clinic can protect the cardiovascular health of patients with both diabetes and cardiovascular disease. * At the Cardio-Metabolic Clinic, pat...
Detailed Description
Background: Despite improved treatment options, cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes. It is crucial to recognize that managing dia...
Eligibility Criteria
Inclusion
- Inclusion:
- \>18 years
- Capable of giving written informed consent
- Established diagnosis of T2D
- Having established heart or vascular disease defined as either:
- Atherosclerotic disease defined as:
- Prior acute coronary syndrome (ACS).
- Chronic coronary syndrome defined as the combination of: Angina pectoris AND coronary atherosclerosis assessed with either Coronary CT angiography (CTA) or Myocardial-scintigraphy (MPI) or Coronary angiography (CAG) AND treatment with statins and/or acetylsalicylic acid.
- Stroke.
- Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation.
- Ischemic heart disease defined by one of the following criteria: a) Myocardial-scintigraphy: \>10% reversibility OR b) Coronary CT angiography: Coronary Artery Calcium (CAC)-score \>100.
- Heart failure (HF): HF with reduced ejection fraction (HFrEF), HF with Mildly reduced ejection fraction (HFmrEF), HF with preserved ejection fraction (HFpEF)
- Atrial fibrillation and/or flutter, including paroxysmal, persistent and chronic disease
- Valvular heart disease (which requires control in outpatient clinic of cardiology), such as aortic valve stenosis, mitral valve insufficiency, and patients with aortic dilatation
- Hypertension treated with at least three antihypertensive drugs
- Exclusion:
- Life expectancy less than 5 years for any reason
- Type 1 Diabetes Mellitus
- Participation in another clinical trial with an investigational product or device that could interfere with the primary and/or secondary endpoints of this study
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2034
Estimated Enrollment :
1600 Patients enrolled
Trial Details
Trial ID
NCT06203860
Start Date
January 1 2024
End Date
May 1 2034
Last Update
July 8 2025
Active Locations (1)
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1
Cardiovascular Research Unit, Odense University Hospital - Svendborg
Svendborg, Region Syddanmark, Denmark, 5700