Cardiovascular Protection in Patients With Type 2 Diabetes and Established Heart or Vascular Disease - The Cardio-Metabolic Clinic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Odense University Hospital
- Enrollment
- 1,600
- Locations
- 1
- Primary Endpoint
- 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).
Study Overview
Brief Summary
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.
Detailed Description
Background:
Despite improved treatment options, cardiovascular disease remains the leading cause of illness and death among patients with type 2 diabetes. It is crucial to recognize that managing diabetes involves more than just controlling blood sugar levels; preventing and treating cardiovascular disease is of significant importance. Lifestyle changes have been proven to have a substantial impact on cardiovascular health. Additionally, remarkable advancements in treatment options with cardiovascular protective effects have occurred over the past five years. Nevertheless, the traditional healthcare system primarily focuses on managing individual diseases, often leading to fragmented care for patients with type 2 diabetes. This fragmented approach often results in inadequate treatment, higher costs, and worse outcomes for cardiovascular disease. To address these challenges, our goal is to establish a Cardio-Metabolic Clinic that adopts a multidisciplinary approach to optimize diabetes management. The clinic will place special emphasis on implementing measures to protect the cardiovascular system and ensure comprehensive care for the patients. By bridging the gap between diabetes management and cardiovascular health, the aim is to enhance cardiovascular outcomes for patients with type 2 diabetes.
Organization in the Cardio-Metabolic Clinic:
The Cardio-Metabolic Clinic, structured on a cost-effective model, operates through a three-layered system centered on the patient. The innermost layer involves medical students or specialized cardio-metabolic nurses who maintain the daily contact with the patients. Patient medical history and baseline visit data are recorded in the Electronic Case-Report Form (Redcap). Upon randomization to the intervention arm, a decision-making algorithm in the Redcap-system is activated, ensuring that patients receive optimal and tailored medical treatment in accordance with the latest guidelines for diabetes management. The second layer includes a cardiologist who, in collaboration with the medical students or cardio-metabolic nurses, reviews the patients' risk profiles and algorithm-recommended treatments. If further counselling is needed for patient management, the third layer, consisting of an endocrinologist, a nephrologist and a hepatologist, will be consulted. This multidisciplinary collaboration ensures the most optimal diabetes management, especially in challenging cases.
Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •>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.
- •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 >
- •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 Criteria
- •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
Arms & Interventions
The Cardio-Metabolic Clinic
Comprising specialized, multidisciplinary management of diabetes and cardiovascular disease in a Cardio-Metabolic Clinic.
Intervention: Cardio-Metabolic Clinic (Other)
Usual Care
Involving collaboration between the general practitioner, and/or the endocrinology outpatient clinic, and/or cardiology outpatient clinic.
Outcomes
Primary Outcomes
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).
Time Frame: From baseline to 5 years of follow-up
Measured in days.
Secondary Outcomes
- Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF.(From baseline to 10 years of follow-up)
- Change in estimated Glomerular Filtration Rate (eGFR)(From baseline to 3 years of follow-up)
- Change in health outcomes measured by quality-adjusted life years (QALY)(From baseline to 5 and 10 years of follow-up)
- Time to first occurrence of a composite heart failure endpoint consisting of: de novo HF and HF hospitalisation.(From baseline to 5 and 10 years of follow-up)
- Change in diabetic retinopathy stage based on eye examination (fundoscopy)(From baseline to 3 years of follow-up)
- 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(From baseline to 3 years of follow-up)
- Time to occurrence of the individual component CV death(From baseline to 5 and 10 years of follow-up)
- Time to occurrence of the individual component AMI.(From baseline to 5 and 10 years of follow-up)
- Time to occurrence of the individual component non-fatal stroke.(From baseline to 5 and 10 years of follow-up)
- Change in urinary albumin-to-creatinine ratio (UACR)(From baseline to 3 years of follow-up)
- 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(From baseline to 3 years of follow-up)
- Change in protocol-driven medication(From baseline to 3 years of follow-up)
- Number of overall symptom burden determined by summing the occurences of CV death, non-fatal myocardial infarction, non-fatal stroke, and hospitalisation for HF.(From baseline to 5 and 10 years of follow-up)
- Change in Chronic Kidney Disease (CKD) stage(From baseline to 3 years of follow-up)
- Change in fibrosis-4 (FIB-4)(From baseline to 3 years of follow-up)
- Change in degree of liver fibrosis in high-risk individuals assessed through a Fibro-scan(From baseline to 3 years of follow-up)
- Change in ankle-brachial pressure index (ABI).(From baseline to 3 years of follow-up)
- Change in symptoms as reported by patients using the Kansas City Cardiomyopathy Questionnaire (KCCQ)(From baseline to 3 years of follow-up)
- Net cost analysis of implementing a Cardio-Metabolic Clinic(From baseline to 5 and 10 years of follow-up)
- Cost-effectiveness ratio of implementing a Cardio-Metabolic Clinic(From baseline to 5 and 10 years of follow-up)