Evaluation of the Risk of Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabet… (NCT07719621) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Risk of Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
50,000 participantsStarted 2026-09
Plain-language summary
The goal of this study, performed entirely with computer programs, is to learn if using a combination of two drugs works better than using one alone, in the treatment of people with chronic kidney disease and type 2 diabetes mellitus.
The main questions it aims to answer are:
* How many events of heart failure, heart failure hospitalizations, and cardiovascular death happen in each group?
* How do serious kidney problems progress in each of the groups?
Researchers will compare reference therapy (finerenone) with a combination of finerenone and empagliflozin.
There will not be human participants in this study. With the help of artificial intelligence, researchers will recreate a large population of people with chronic kidney disease and type 2 diabetes mellitus. Data on their disease, treatment, and laboratory parameters will be based on and simulated using real data from previous clinical trials conducted with real participants.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking how quickly serious events like heart failure, hospitalization, or cardiovascular death occur in people who already have both chronic kidney disease and type 2 diabetes — given that I have these conditions, does my doctor think my current risk level is high enough that being closely monitored in a study like this would give me useful information about my own health?
2Since this trial isn't recruiting yet, how much time might pass before it opens, and in the meantime what is my doctor doing to actively monitor my heart and kidney function given that I have both CKD and type 2 diabetes?
3One of the things this study measures is a 40–57% decline in eGFR from my baseline — can my doctor explain what my current eGFR is, what that decline would actually mean for my kidney function, and whether I'm already showing any warning signs heading in that direction?
4This appears to be an observational study rather than a treatment trial, so would joining it change anything about the care I receive, or would it mainly involve being monitored and having my outcomes recorded over time?
5Are there active treatment trials or standard-of-care options — like SGLT2 inhibitors or GLP-1 medications — that my doctor thinks I should consider now to try to reduce my risk of the exact outcomes this study is tracking, like heart failure or end-stage kidney disease?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Occurrence of Incident Heart Failure, Heart Failure Hospitalization, or Cardiovascular Death
Timeframe: From the beginning of the simulation up to 10 years
2
Time to Onset of End-Stage Kidney Disease, Sustained eGFR <15 ml/min/1.73 m², or ≥40-57% Decline in eGFR from Baseline
Timeframe: From the beginning of the simulation up to 10 years