Experimental Designs for Multicomponent Interventions in Kidney and Cardiometabolic Diseases.
Peter Rossing
https://pubmed.ncbi.nlm.nih.gov/39078403Actively Recruiting
Phase 3
Age: 40Years - 90Years
All Genders
ID06082063
Multifactorial Intervention to Reduce Cardiovascular Disease in People with Type 1 Diabetes at High Risk A Randomized Study Comparing Intensive Therapy to Standard Care
Led by Steno Diabetes Center Copenhagen · Updated on 2025-01-10
2000
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Steno Diabetes Center Copenhagen
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a multifactorial intervention (MFI) to reduce cardiovascular disease (CVD) risk in individuals with type 1 diabetes (T1D) who are at high risk of CVD. This phase 3 study includes 2000 participants aged 40 to 90 years with T1D for more than 10 years and additional risk factors such as chronic kidney disease (CKD), heart failure, obesity, or a high 10-year CVD risk. The goal is to test whether MFI with ambitious treatment targets can reduce major adverse cardiovascular events (MACE) and hospitalization for heart failure (HHF) compared to current standard care over a 5-year follow-up period. Participants are randomly assigned by center clusters to either standard care or intensive multifactorial risk-based therapy. The intensive group receives individualized treatment including medications such as semaglutide, sotagliflozin, finerenone, ezetimibe, and PCSK9 inhibitors based on their risk profile. All participants take aspirin 75 mg once daily unless contraindicated. The study uses a prospective, randomized, open-label design with blinded endpoint evaluation to compare outcomes between the groups. During the study, participants undergo regular monitoring of cardiovascular and kidney health, safety assessments, and evaluations of treatment adherence. Researchers will measure time to first MACE or HHF as the primary outcome. Secondary outcomes include all-cause mortality, kidney function decline, and frequency of diabetic ketoacidosis. The total participation duration is 5 years, with ongoing follow-up to assess the long-term effects of the interventions.
CONDITIONS
Official Title
Multifactorial Intervention to Reduce Cardiovascular Disease in Type 1 Diabetes
Who Can Participate
Age: 40Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Given written informed consent
- Male or female patients aged 40 years or older with type 1 diabetes diagnosed before age 30 with insulin from onset, or if diagnosed after 30, insulin from onset plus diabetic ketoacidosis or positive autoantibodies, with diabetes duration over 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 heart attack, stroke, or angina), or history of heart failure, or obesity grade 2 or 3 (BMI >35 kg/m2), or 10-year cardiovascular disease risk over 10% according to the Steno Type 1 Risk Engine
- Fertile females must use highly effective chemical, hormonal, or mechanical contraception during the study and for at least 2 months after stopping study drugs, or be menopausal, surgically sterilized, or hysterectomized for at least 12 months prior to screening
- Ability to communicate with the investigator and understand informed consent
You will not qualify if you...
- Type 2 diabetes, MODY, or secondary diabetes
- History of pancreatitis
- Body mass index less than 18.5 kg/m2
- Females of childbearing potential who are pregnant, breastfeeding, planning pregnancy, or not using adequate contraception
- Known or suspected abuse of alcohol or recreational drugs
- Participation in another intervention study
- Chronic kidney disease stage 5
AI-Screening
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1
2
3
Trial Site Locations
Total: 2 locations
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
2
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Actively Recruiting
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Research Team
F
Frederik Persson, MD, DMSc
E
Elisabeth Stougaard, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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