Type 1 diabetes
Conditions
Brief summary
• 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.
Detailed description
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.
Interventions
Sponsors
Steno Diabetes Center Copenhagen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Denmark
Outcome results
None listed