NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients
This research is exploring whether higher doses of specific heart medications, called RAS-antagonists and beta-blockers, can effectively prevent heart-related issues in individuals with Type 2 diabetes who do not currently have heart disease. Researchers are particularly interested in those with a higher level of a blood marker called NT-proBNP, which can indicate a greater risk of future heart problems. The study aims to compare the effects of these higher doses against standard treatment, hoping to reduce hospital stays or deaths caused by heart events. It also considers the economic impact and includes a special part for some participants to check for early eye and nerve damage related to diabetes.
At a glance
What is this study about?
This study is looking into a way to help people with Type 2 diabetes avoid heart problems. If you have Type 2 diabetes, you might be at a higher risk of heart disease, even if you haven't had any symptoms yet. This research wants to see if giving higher doses of two common types of heart medications – called RAS-antagonists and beta-blockers – can actually stop heart problems from happening in the first place.
The researchers are particularly focusing on people who have Type 2 diabetes and who have a certain marker in their blood called NT-proBNP. Higher levels of NT-proBNP can suggest a higher chance of future heart issues. The study will compare taking these higher doses of medication with the usual care, to see if it makes a difference in preventing unplanned hospital visits or even death due to heart events. They also want to understand if this approach is good value for money for the NHS.
There's also a special part of the study for some participants in specific locations, which will check for very early signs of eye and nerve damage that can be linked to diabetes. This could help us understand more about how diabetes affects different parts of the body and if these medications can help with that too.
Key takeaways
- Aims to prevent heart problems in Type 2 diabetes.
- Investigates higher doses of common heart medications.
- Focuses on people without existing heart disease.
- Looks at a blood marker (NT-proBNP) to identify risk.
- Compares study drugs to standard diabetes care.
- Includes a special check for early eye and nerve damage.
Who may be eligible?
To be part of this study, you need to be at least 18 years old and have been diagnosed with Type 2 diabetes for at least six months. You also must not have any signs or history of heart disease already. It's really important that you're able to understand and agree to all parts of the study and follow the instructions carefully.
There are also some reasons why you might not be able to join. For example, if you've had a bad reaction to these types of heart medications before, or if you're already taking the maximum dose of them. If your kidney function isn't good, or if your blood pressure or heart rate is very low, you wouldn't be able to participate. Also, if tests show signs of existing heart problems, or if you have other serious illnesses that mean you mightn't live for at least two more years, you wouldn't be eligible.
Women who could become pregnant also have specific rules انہوں نے کہ اگر ان کی تولیدی صحت اس بات کی اجازت دیتی ہے تو وہ حصہ نہیں لے سکتیں جب تک کہ وہ بچے کی پیدائش کی صلاحیت سے محروم نہ ہو جائیں۔ (e.g., passed menopause or had certain surgeries). The study aims to screen about 3000 people to find around 2400 who are suitable.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you had Type 2 diabetes for at least 6 months?
- Do you have no known heart disease or heart problems?
- Are you not currently on the highest dose of heart medications called RAS-antagonists or beta-blockers?
- Are your kidneys generally healthy (creatinine not too high)?
- Are you willing and able to attend study visits and follow instructions?
What does participation involve?
If you join this study, you will be randomly placed into one of two groups: either you'll receive a higher dose of the study medications (RAS-antagonists and beta-blockers) or you'll continue with standard treatment. This decision is made by chance, like flipping a coin. You'll have regular visits to the clinic so doctors can monitor your health, check how you're reacting to the medication, and make sure everything is going well. These visits will likely include blood tests, blood pressure checks, and possibly heart scans. The exact number of visits and tests will be explained to you fully before you agree to participate. You would also have ongoing follow-up to track your health over time. The total duration of your participation in the study will be clearly outlined by the research team.
Potential risks and benefits
Locations (21)
- Internistische OrdinationVerified postcodeMödling, Austria· Active not recruiting
- Klinischen Abteilung für Endokrinologie und Diabetologie MU GrazVerified postcodeGraz, Austria· Recruiting
- Konventhospital der Barmherzigen Brüder Abteilung für Innere MedizinVerified postcodeLinz, Austria· Recruiting
- Krankenanstalt Rudolfstiftung, 1. Medizinische AbteilungVerified postcodeVienna, Austria· Completed
- Zentrum für Klinische StudienVerified postcodeVienna, Austria· Terminated
- Medical University of Vienna Univ.Clinic for Internal Medicine II Department of CardiologyVerified postcodeVienna, Austria· Recruiting
- Univ. Klinik für Innere Medizin III Med. Uni WienVerified postcodeVienna, Austria· Recruiting
- Universitätsklinik für Augenheilkunde und Optometrie Medizinische Universität WienVerified postcodeVienna, Austria· Recruiting
- Diabetes & Stoffwechselambulanz Gesundheitszentrum Wien SüdVerified postcodeVienna, Austria· Recruiting
- 3. Med. Abtlg., KH Hietzing mit Neurologischem Zentrum RosenhügelVerified postcodeVienna, Austria· Terminated
- iMED19Verified postcodeVienna, Austria· Recruiting
- Maastricht University Medical Center; Dep. CardiologyVerified postcodeMaastricht, Netherlands· Active not recruiting
Common questions
What are RAS-antagonists and beta-blockers?
These are common medications used to treat high blood pressure and other heart conditions. They help your heart work more easily.
What is NT-proBNP?
NT-proBNP is a substance found in your blood. Higher levels can sometimes show that your heart is under stress and might be at a greater risk of future problems.
Will I know if I'm getting the higher dose or standard treatment?
In this type of study, participants are usually 'blinded', meaning you won't know which group you are in. This helps ensure fair results.
Can I continue my other diabetes medicines?
Generally, yes, you will continue your usual diabetes care. The study medications are added on top of your existing treatment, but this will be checked carefully by the study doctors.
What happens if I experience side effects?
The study team will monitor you closely. If you experience any side effects, you should report them immediately, and the doctors will guide you on the next steps.
How to find out more
Martin Huelsmann, Doz.Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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