Diabetes Mellitus, Type 2 Clinical Trial
— ProtecT-2-DOfficial title:
Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
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 | Recruiting |
Enrollment | 1600 |
Est. completion date | May 1, 2034 |
Est. primary completion date | May 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Cardiovascular Research Unit, Odense University Hospital - Svendborg | Svendborg | South Denmark |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first occurrence of major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for heart failure (HF). | Measured in days. | From baseline to 5 years of follow-up | |
Secondary | Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF. | Measured in days. | From baseline to 10 years of follow-up | |
Secondary | Time to occurrence of the individual component CV death | Measured in days. Including: acute myocardial infarction, venous thromboembolic event, malignant arrhythmia, cardiogenic shock, fatal stroke and aorta dissection. |
From baseline to 5 and 10 years of follow-up | |
Secondary | Time to occurrence of the individual component AMI. | Measured in days. Including: ST-elevation myocardium infarction and non-ST-elevation myocardium infarction |
From baseline to 5 and 10 years of follow-up | |
Secondary | Time to occurrence of the individual component non-fatal stroke. | Measured in days. Including: Thromboembolic or undetermined |
From baseline to 5 and 10 years of follow-up | |
Secondary | Time to first occurrence of a composite heart failure endpoint consisting of: de novo HF and HF hospitalisation. | Measured in days. | From baseline to 5 and 10 years of follow-up | |
Secondary | Number of overall symptom burden determined by summing the occurences of CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF. | Measured in count of events. | From baseline to 5 and 10 years of follow-up | |
Secondary | Change in diabetic retinopathy stage based on eye examination (fundoscopy) | Measured in ratio to baseline. | From baseline to 3 years of follow-up | |
Secondary | Change in estimated Glomerular Filtration Rate (eGFR) | Measured in in ratio to baseline [mL/min/1.73 m^2] Creatinine-based. |
From baseline to 3 years of follow-up | |
Secondary | Change in urinary albumin-to-creatinine ratio (UACR) | Measured in ratio to baseline. | From baseline to 3 years of follow-up | |
Secondary | Change in Chronic Kidney Disease (CKD) stage | Measured in ratio to baseline. Calculated by eGFR and albuminuria. |
From baseline to 3 years of follow-up | |
Secondary | Time to first occurrence of a composite CKD endpoint consisting of a decline in eGFR [mL/min/1.73 m²] of more than 50%, onset of end-stage kidney disease (dialysis, eGFR<15, kidney transplantation) or death from renal or CV causes | Measured in count of events. | From baseline to 3 years of follow-up | |
Secondary | Change in fibrosis-4 (FIB-4) | Measured in ratio to baseline. FIB-4 is a biomarker assessing degree of liver fibrosis. Calculated using age, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), and platelet count. |
From baseline to 3 years of follow-up | |
Secondary | Change in degree of liver fibrosis in high-risk individuals assessed through a Fibro-scan | Measured in count of events. | From baseline to 3 years of follow-up | |
Secondary | Time to first occurrence of a composite macrovascular diabetic complications endpoint comprising new diagnosis of lower extremity arterial disease (LEAD), new/progression of foot ulcers, surgical procedures related to PAD, and coronary revascularisation | Measured in count of events. Surgical procedures in relation to PAD includes: percutaneous transluminal angioplasty, peripheral artery bypass, thrombectomy, thrombolysis, amputations. Coronary revascularisation includes: percutaneous coronary intervention (PCI), and/or coronary artery bypass graft. |
From baseline to 3 years of follow-up | |
Secondary | Change in ankle-brachial pressure index (ABI). | Measured in ratio to baseline. | From baseline to 3 years of follow-up | |
Secondary | Change in protocol-driven medication | Measured in percentage (%). Protocol-driven medication includes: Lipid lowering medication Antihypertensive medication Anti-thrombotic medication Anti-diabetic medication Nephro-protective medication |
From baseline to 3 years of follow-up | |
Secondary | Change in symptoms as reported by patients using the Kansas City Cardiomyopathy Questionnaire (KCCQ) | Measured in score points (change in percentage [%]) | From baseline to 3 years of follow-up | |
Secondary | Net cost analysis of implementing a Cardio-Metabolic Clinic | Measured in dollars [$]. Cost of Cardio-Metabolic Clinic minus averted costs ( including averted admissions, medical treatment, and productivity). |
From baseline to 5 and 10 years of follow-up | |
Secondary | Change in health outcomes measured by quality-adjusted life years (QALY) | Measured in score points (change in percentage [%]) | From baseline to 5 and 10 years of follow-up | |
Secondary | Cost-effectiveness ratio of implementing a Cardio-Metabolic Clinic | Measured as: Net costs/change in health outcomes [$/QALY] | From baseline to 5 and 10 years of follow-up |
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