NCT06203860Recruiting
The Cardio-Metabolic Clinic
Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
Source: ClinicalTrials.gov · Last updated 8 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1600 (estimated)
- First submitted
- 10 Dec 2023
- Start date
- 1 Jan 2024
- Primary completion date
- 1 May 2029
- Lead sponsor
- Odense University Hospital
- NCT number
- NCT06203860
What you commit to
- Study type: Interventional
- Planned participants: 1600
- From 1 Jan 2024 to the primary completion date, 1 May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular Research Unit, Odense University Hospital - Svendborg Coordinator of this site? Confirm its status | Svendborg | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.