Study on Preventing Heart Disease in Diabetes Patients Using Eprosartan Mesilate and Drug Combination

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What is this study about?

This clinical trial focuses on preventing heart disease in patients with Type 2 Diabetes who do not have a history of heart disease. The study uses a special blood test called NT-proBNP to identify patients who might benefit from treatment. The main goal is to see if high doses of certain medications can reduce the risk of unplanned hospital visits or death due to heart problems. These medications include RAS-antagonists and beta-blockers, which are commonly used to manage blood pressure and heart conditions.

Participants in the study will be randomly assigned to receive either the high-dose treatment or a conventional therapy. The study will last for up to 24 months, during which participants will take the medications orally. The effectiveness of the treatment will be assessed by monitoring the occurrence of heart-related hospitalizations or deaths. The study will also look at other factors, such as overall hospitalizations and the levels of NT-proBNP in the blood.

The trial aims to provide valuable information on whether a more intensive treatment approach can better prevent heart issues in people with Type 2 Diabetes. By comparing the outcomes of the two treatment groups, researchers hope to determine the best strategy for reducing heart-related risks in this population. The study is expected to conclude by early 2026.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as having type-2 diabetes for at least six months and being 18 years or older.

Written consent is required to participate, ensuring understanding and agreement to comply with study requirements.

2 initial assessment

An initial assessment is conducted to measure the NT-proBNP level, a specific parameter used to evaluate heart health.

This assessment helps determine the appropriate treatment group for participation.

3 treatment allocation

Participants are randomly assigned to receive either high-dose treatment with RAS-antagonists and beta-blockers or conventional therapy.

The goal is to compare the effectiveness of these treatments in reducing unplanned hospitalizations or cardiac events.

4 medication administration

Medications are administered orally. The specific medications include options such as eprosartan, zofenopril, quinapril, ramipril, fosinopril, carvedilol, nebivolol, losartan, cilazapril, valsartan, metoprolol, bisoprolol, candesartan, enalapril, lisinopril, irbesartan, perindopril, spirapril, and captopril.

The dosage and frequency are determined based on the treatment group and individual health needs.

5 ongoing monitoring

Regular monitoring is conducted to track health status and any changes in the NT-proBNP level.

This includes assessments of cardiac health and any hospitalizations related to heart conditions.

6 study completion

The study is expected to conclude by January 31, 2026.

Final assessments will be conducted to evaluate the effectiveness of the treatments in preventing cardiac events.

Who Can Join the Study?

Have been diagnosed with Type-2 diabetes mellitus for at least six months. This is a condition where the body has trouble using sugar properly.
Be at least 18 years old. Both men and women can participate.
Provide written informed consent, which means you agree to participate in the study and understand what it involves.
Be able to follow all the study requirements.

Who Cannot Join the Study?

Patients who do not have Type 2 Diabetes Mellitus cannot participate. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients with a NT-proBNP level of 125 pg/ml or lower cannot participate. NT-proBNP is a blood test that helps measure heart stress or damage.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Imed19-Privat	Vienna	Austria
ÖGK Mein Gesundheitszentrum Favoriten	Vienna	Austria
Medical University Of Vienna	Vienna	Austria
Medical University Of Graz	Graz	Austria

Other Sites

Site Name	City	Country
Dya Dvsciulsleo &zbiz Dzo Gqrhxvxr Gqqxelwlobars Ffxk Ijpyfa Mxjkndl Ufe Kwolguykbvq Ok	Vienna	Austria
Odifykwdcc Dba Fhaystpi	Mödling	Austria
Hyuuapgx Dl Lr Sdhbc Csfq I Sfjd Pgx	Barcelona	Spain
Hgceivob Udyexwcktkxej Hctnqtkd Tgovq y Pkyhoq Irmgmgvv Cugxgq dmrfwsbofyuqnvqno (pcrn	Badalona	Spain
Kkgrrbp Dwq Bdlrkvmuuiap Bosffkp	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not yet recruiting	22.02.2016
Spain	Not yet recruiting	22.02.2016

Trial locations

Investigated drugs:

RAS-antagonists are medications that help relax blood vessels by blocking the action of certain hormones that tighten them. This can lower blood pressure and reduce the strain on the heart, which is particularly beneficial for patients with diabetes who are at risk of heart problems.

Beta-blockers are medications that reduce the heart rate and the heart’s workload by blocking the effects of adrenaline. This can help prevent heart attacks and other cardiac events, especially in patients with diabetes who have a higher risk of heart disease.

Investigated diseases:

Type 2 diabetes mellitus

Diabetes mellitus Type 2 – This is a chronic condition that affects the way the body processes blood sugar (glucose). In this disease, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn’t produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, including damage to the eyes, kidneys, nerves, and heart. The progression of Type 2 diabetes is often gradual, and symptoms may develop slowly, making it difficult to detect in the early stages. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Managing blood sugar levels is crucial to prevent complications and maintain overall health.

Trial ID:

2024-519051-28-01

NCT ID:

NCT02817360

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Heart Disease in Diabetes Patients Using Eprosartan Mesilate and Drug Combination

What is this study about?

Who Can Join the Study?

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