Multifactorial intervention to reduce cardiovascular disease in type 1 diabetes
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 15
- 主要终点
- • First major adverse cardiovascular events (MACE), and first hospitalization for heart failure (HHF). The primary efficacy analysis will analyse if a multifactorial intervention strategy is superior to standard care with respect to time to first event of the composite endpoint of first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure five years after inclusion of the first patient.
研究概览
简要总结
The aim of the Steno 1 study is to test a strategy of intensified care based on MFI in individuals with T1D at high risk of CVD with ambitious treatment targets compared to standard of care, while simultaneously investigating the safety and efficacy of 40 mg finerenone in individuals with T1D in risk of CV death and hospitalization for heart failure (HHF )
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Given written informed consent
- •Male or female patients ≥40 years old with type 1 diabetes (diagnosis before age 30 with insulin from onset or if diagnosis after 30 years of age insulin from onset and DKA or positive autoantibodies ( in accordance with local guidelines)), or confirmed, at the investigator discretion by the available medical records) during >10 years
- •Presence of chronic kidney disease (UACR >30 mg/g or eGFR < 60 ml/min/1.73 m2) OR history of ischemic heart disease (previous myocardial infarction, stroke or angina) OR history of heart failure OR obesity grade 2 and 3 (BMI>35 kg/m2) OR 10-year CVD risk >10% according to Steno Type 1 Risk Engine
- •Fertile females must use highly efficient chemical, hormonal and mechanical contraceptives during the whole study and at least 2 months after cessation of study drug. The following contraceptive methods are approved: IUD or hormonal contraception that inhibits ovulation, i.e. pills, implantations, transdermal patches, vaginal ring or depot injection. Alternatively, be in menopause (i.e. must not have had regular menstrual bleeding for at least one year), have undergone bilateral oophorectomy or have been surgically sterilized or hysterectomised at least 12 months prior to screening. Fertile participants will be pregnancy tested every six months with urine HCG
- •Ability to communicate with the investigator and understand informed consent
- •For the CGM sub-study: Using CGM at inclusion, as part of their usual diabetes treatment.
排除标准
- •Type 2 diabetes, MODY, secondary diabetes.
- •History of pancreatitis
- •Body mass index < 18.5 kg/m2
- •Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant or are not using adequate contraceptive methods
- •Known or suspected abuse of alcohol or recreational drugs.
- •CKD stage 5
- •Participant in another drug-intervention study
- •For the sub-study on CGM if for some reason the participant chooses no longer to use CGM
结局指标
主要结局
• First major adverse cardiovascular events (MACE), and first hospitalization for heart failure (HHF). The primary efficacy analysis will analyse if a multifactorial intervention strategy is superior to standard care with respect to time to first event of the composite endpoint of first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure five years after inclusion of the first patient.
• First major adverse cardiovascular events (MACE), and first hospitalization for heart failure (HHF). The primary efficacy analysis will analyse if a multifactorial intervention strategy is superior to standard care with respect to time to first event of the composite endpoint of first non-fatal myocardial infarction, first non-fatal stroke, cardiovascular death or first hospitalization for heart failure five years after inclusion of the first patient.
次要结局
- Will determine whether a multifactorial intervention is superior to standard care with respect time to a composite endpoint of renal function (end-stage kidney disease (ESKD) (dialysis, renal death, transplantation) a sustained eGFR <15 ml/min/1.73 m2 or >50% sustained decline in eGFR from baseline) compared to standard of care (sustained means change in eGFR sustained for at least 30 days).
- To determine the effect of multifactorial intervention is superior to standard of care with respect to the individual components of the composite endpoints.
- To determine whether a multifactorial intervention is superior to standard care with respect to all-cause mortality.
研究者
Frederik Persson
Scientific
Steno Diabetes Center Copenhagen