MD, PhD
Elisabeth B Stougaard
Steno Diabetes Center Copenhagen
| Project management | ||
| Project status | Open | |
| Data collection dates | ||
| Start | 01.07.2024 | |
| End | 01.07.2029 | |
Multifactorial intervention to reduce cardiovascular disease in T1D A prospective, randomised, open-labelled, multi-center study
Short summary
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, Design: Prospective, parallel-group randomised, open, blinded endpoint. The study is a superiority trial. The primary endpoint is to determine whether an intensified strategy based on MFI is superior to standard care with respect to development of MACE+HHF
Rationale
Individuals with type 1 diabetes (T1D) are at high risk for cardiovascular disease (CVD). Even with optimal glycaemic control, the risk is doubled compared to healthy individuals. Treatment of type 2 diabetes (T2D) is based on multifactorial intervention (MFI). The development of new drug classes has had profound impact on treatment guidelines through a documented reduction in mortality and morbidity in individuals with T2D. MFI acknowledges the need for interventions directed towards several risk factors for CVD, and not focus merely on glucose levels. A fundamental change in risk management with a strong focus on MFIs to lower CVD risk in individuals with T1D and comorbidity of CVD, Chronic kidney disease (CKD), Heart failure (HF) or obesity, has the potential to improve morbidity and survival in T1D. Objective: 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). We hypothesize, that intensive treatment based on MFI reduces major adverse cardiovascular endpoints (MACE), hospitalization for heart failure (HHF), progression of kidney disease and mortality.
Description of the cohort
Patient population: High-risk individuals with T1D of >10 years duration (>40 years of age with presence of either CKD, CVD, HF, obesity or a >10% 5-year CVD risk determined by the Steno T1 Risk Engine). Participants are recruited from Steno Diabetes Centres or partner clinics which will constitute the sites.
Data and biological material
Blood samples, urine samples, questionnaires, data from medical records. Samples (blood and urine) for a research biobank and a biobank for future research
Collaborating researchers and departments
Steno Diabetes Center Aarhus/North Jutland,/Odense/Zealand/Greenland/Faraoe Islands and 10 partner hospitals in Denmark