A clinic focused on improving heart health for diabetes patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a specialized Cardio-Metabolic Clinic in enhancing cardiovascular health for patients with type 2 diabetes and existing cardiovascular diseases. Patients will receive comprehensive care that includes a systematic approach to their overall health and aggressive treatment with heart-protective medications. The study compares outcomes from the Cardio-Metabolic Clinic to standard care to determine differences in cardiovascular illness and mortality rates. The aim is to bridge the gap between diabetes management and cardiovascular health, ultimately improving patient outcomes.

Why it matters

Who can join: the full rules

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:

  1. Prior acute coronary syndrome (ACS).
  2. 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.
  3. Stroke.
  4. Peripheral arterial disease (PAD) defined as: Claudication intermittence in combination with pathological ABI AND/OR vascular PAD surgery AND/OR ischemic amputation.
  5. 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 it's running

• Cardiovascular Research Unit, Odense University Hospital - Svendborg
  Svendborg, Region Syddanmark, Denmark Recruiting

Study contacts

• Principal investigator: Soeren Auscher, M.D, Ph.D — Cardiovascular Research Unit. Odense University Hospital, Svendborg
• Study coordinator: Soeren Auscher, M.D, Ph.D
• Email: Soeren.Auscher@rsyd.dk
• Phone: +45 6320 2402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.