Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

4 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital De La Santa Creu I Sant Pau
Verified
Barcelona, Spain
Hospital Universitario Hermanos Trias y Pujol. Institut Catalá d'Oncología (ICO)
Verified
Badalona, Spain
Konvent Der Barmherzigen Brueder
Verified
Linz, Austria

Trial locations

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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.

What is already known about the treatment

RAS-antagonists
These medications are typically taken orally and work by blocking the renin-angiotensin system, which helps regulate blood pressure and fluid balance. They are well-established in medical literature and are commonly used to treat high blood pressure and heart failure. In this clinical trial, they are being tested for their effectiveness in preventing cardiac events in patients with Type 2 Diabetes who have elevated NT-proBNP levels. By inhibiting the action of angiotensin, they help relax blood vessels, reducing blood pressure and strain on the heart.
Beta-blockers
Administered orally, beta-blockers are used to manage abnormal heart rhythms and protect the heart from a second heart attack after a first heart attack. They are widely recognized in medical literature and are used to treat high blood pressure, angina, and heart failure. In the context of this trial, they are being evaluated for their potential to reduce cardiac events in diabetic patients with high NT-proBNP levels. They work by blocking the effects of adrenaline on the heart, slowing the heart rate, and reducing blood pressure, which decreases the heart's demand for oxygen.

Investigated diseases

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.