A clinic focused on improving heart health for diabetes patients
Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
NA · Odense University Hospital · NCT06203860
This study is testing whether a special clinic that focuses on heart health can help people with type 2 diabetes and heart problems feel better and live longer compared to regular care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital (other) |
| Locations | 1 site (Svendborg, Region Syddanmark) |
| Trial ID | NCT06203860 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of type 2 diabetes and established cardiovascular disease.
Not a fit: Patients without a diagnosis of type 2 diabetes or those without cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce cardiovascular complications and mortality in patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promise in integrated care approaches for diabetes and cardiovascular health, suggesting potential success for this novel clinic model.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Svendborg, Region Syddanmark
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Cardiovascular death, Heart attack, Stroke, Heart failure, Diabetic microvascular complications, Diabetic macrovascular complications