This study focuses on people who have three medical conditions: Type 2 diabetes, hypertension (high blood pressure), and cardiovascular disease (heart and blood vessel disease). The research examines a combination of two medications: empagliflozin (Jardiance) and vicadrostat (BI 690517), compared to treatment with empagliflozin and placebo. Both medications are taken as tablets by mouth.
The purpose is to determine if using both medications together works better than empagliflozin alone in preventing serious heart-related health issues in people with these three conditions. The study will particularly look at how well this combination prevents death from heart problems and reduces the need for hospital visits due to heart failure.
Participants in this study will receive treatment for about 51 months. During this time, they will take either the combination of both medicines or empagliflozin with a placebo. Their blood pressure, kidney function, and heart health will be monitored throughout the study period. The medications being tested are designed to help manage blood sugar levels and blood pressure while protecting the heart and blood vessels.
1Initial medication phase
You will receive empagliflozin (Jardiance) 10 mg tablets to take by mouth
You will also receive either vicadrostat (BI 690517) tablets or a placebo (inactive tablet that looks the same)
You will need to take these medications daily as directed by your doctor
224-week assessment period
Your blood pressure will be measured and compared to your starting values
Your urine will be tested to measure protein levels
Your doctor will monitor your heart and kidney function
3Long-term follow-up
Regular check-ups will continue until October 2029
Your doctor will monitor for any heart-related events
Your kidney function will be regularly assessed
Your blood pressure will be checked at scheduled visits
4Health monitoring
Your heart health will be regularly monitored throughout the study
Any hospital visits related to heart problems will be documented
Your blood pressure and general health status will be regularly checked
5Study completion
The study will end in October 2029
A final health assessment will be conducted
Your doctor will provide recommendations for continuing care after the study ends
Who Can Join the Study?
Must be at least 18 years old when agreeing to participate in the study
Must provide written informed consent to participate in the trial
Both men and women can participate. Women who can become pregnant must use highly effective birth control methods that have less than 1% failure rate per year
Must have high blood pressure (hypertension) and be currently receiving medical treatment for it
Must have Type 2 diabetes and be currently receiving medical treatment for it
Must have established cardiovascular disease (heart and blood vessel disease) and be currently receiving medical treatment for it
Must have at least one additional risk factor that could lead to heart failure (a condition where the heart cannot pump blood effectively)
Who Cannot Join the Study?
History of severe allergic reactions to any of the study medications
Chronic kidney disease (severe problems with kidney function) requiring dialysis
Liver disease that significantly affects liver function
Vicadrostat (BI 690517) is a medication being studied for treating patients who have type 2 diabetes, high blood pressure, and cardiovascular disease. This medication is being tested as a new treatment option to help reduce cardiovascular-related health issues.
Empagliflozin is a medication already used to treat type 2 diabetes. It works by helping the kidneys remove excess sugar from the blood through urine. It also has beneficial effects on heart health and can help reduce the risk of cardiovascular events in people with type 2 diabetes and heart disease.
The trial is studying how these two medications work together compared to using empagliflozin alone. The goal is to see if the combination can better prevent serious heart-related problems, including death from cardiovascular causes, hospitalization due to heart failure, or urgent visits due to heart failure.
Cardiovascular Disease – A group of conditions affecting the heart and blood vessels. It develops when arteries become narrowed or blocked due to the buildup of fatty deposits on their inner walls. The condition often progresses gradually over many years, affecting blood flow throughout the body. The disease can involve multiple parts of the cardiovascular system, including the heart muscle, valves, and circulation.
Type 2 Diabetes – A chronic metabolic disorder characterized by high blood sugar levels due to the body’s ineffective use of insulin. The condition develops when the body becomes resistant to insulin or doesn’t produce enough insulin to maintain normal glucose levels. It typically develops gradually, with symptoms becoming more noticeable over time. The body’s cells become less responsive to insulin, affecting how glucose is processed.
Hypertension – A chronic condition where blood pressure in the arteries is consistently elevated above normal levels. The condition develops when the force of blood pushing against vessel walls remains too high for extended periods. It often develops gradually without noticeable symptoms. The increased pressure puts additional stress on the heart and blood vessels.
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