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About this study

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, patients will receive a specialized and comprehensive care. This includes applying a systematic approach, considering their whole health based on the latest knowledge in the field, and administering aggressive treatment with heart protective medications. * The ProtecT-2-D trial will compare the effects of care at the Cardio-Metabolic Clinic to usual care to see if there are any differences in cardiovascular illness and death.

Condition
Diabetes Mellitus, Type 2, Cardiovascular Diseases
Tested
Cardio-Metabolic Clinic
Sponsor
Odense University Hospital

Who can join

Age
19 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 21

  • Minimum age: 19 years
  • Study condition: Diabetes Mellitus, Type 2, Cardiovascular Diseases
  • 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

Where

1 site, 1 recruiting

Cardiovascular Research Unit, Odense University Hospital - Svendborg

Svendborg, Region Syddanmark, Denmark

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.