Recruiting

Study on the Effects of Ramipril, Bisoprolol, and Dapagliflozin in Patients with ST-Elevation Myocardial Infarction (Heart Attack)

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 is focused on studying the effects of certain medications on patients who have experienced a type of heart attack known as ST-elevation myocardial infarction (STEMI). The medications being tested include Ramipril, Bisoprolol, and Dapagliflozin. These drugs belong to different classes: Ramipril is an angiotensin converting enzyme inhibitor (ACEI), Bisoprolol is a beta blocker, and Dapagliflozin is a sodium/glucose cotransporter 2 (SGLT2) inhibitor. The purpose of the study is to understand how these medications, when given immediately or later, affect heart function and certain markers in the blood after a heart attack.

Participants in the study will receive either the medications or a placebo. The study will monitor changes in heart function using a test called echocardiography, which uses sound waves to create images of the heart. The study will also measure specific blood markers that indicate heart health. These assessments will help determine the impact of the medications on heart recovery after a heart attack.

The study will take place over a period of time, with participants being monitored at various intervals. The main focus will be on heart function and recovery within the first week after treatment, with additional follow-ups to assess longer-term effects. This research aims to provide valuable insights into the best timing and combination of these medications for improving outcomes in patients with STEMI.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after experiencing a heart attack known as ST-elevation myocardial infarction (STEMI) and undergoing a procedure called primary percutaneous coronary intervention (PCI) within 6 hours of symptom onset.
Informed consent is required to participate in the study.
Step 2
Medication administration
The study examines the effects of three medications: ramipril, bisoprolol, and dapagliflozin. These medications are taken orally.
The timing of medication administration is a key focus, comparing immediate versus delayed administration.
Step 3
Monitoring and assessments
On day 7, an echocardiogram is performed to measure the heart's function, specifically looking at the global longitudinal strain (GLS).
Blood tests are conducted to measure NT-proBNP levels, a marker of heart stress, on day 7.
Step 4
Follow-up evaluations
At 30 days, additional assessments include measuring the area under the curve of cardiac troponin-T and troponin-I, which are indicators of heart muscle damage.
A cardiac magnetic resonance imaging (CMRI) scan is performed to assess the size of the heart attack.

Who can join the trial?

6 criteria

Patients must have a condition called **ST-elevation myocardial infarction (STEMI)**, which is a type of heart attack.
Patients should undergo a procedure called **primary PCI** (Percutaneous Coronary Intervention) within 6 hours after their heart attack symptoms start. This procedure helps open blocked blood vessels in the heart.
Patients need to provide **informed consent**, which means they agree to participate in the study after understanding what it involves.
Both **male and female** patients can participate.
Patients of different age groups are eligible, but specific age ranges are not detailed here.
The study does not include vulnerable populations, which means it focuses on individuals who can make decisions for themselves.

Who cannot join the trial?

5 criteria

Patients who have had a recent **heart attack** or **myocardial infarction**. This is when blood flow to the heart is blocked, causing damage to the heart muscle.
Patients with **myocardial ischemia**, which means the heart muscle is not getting enough blood and oxygen.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria set by the study.

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Verified sites

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Verified
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden

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Investigated drugs

Beta blockers
are medications that help reduce the heart's workload and lower blood pressure. They work by blocking the effects of adrenaline on the heart, which slows down the heart rate and makes it easier for the heart to pump blood. In this trial, they are being studied to see how they affect heart function after a heart attack.
Angiotensin converting enzyme inhibitors (ACEI)
are drugs that help relax blood vessels and lower blood pressure. They do this by blocking the formation of a substance that narrows blood vessels. This can help improve blood flow and reduce the strain on the heart. The trial is investigating their impact on heart recovery following a heart attack.
Sodium/glucose cotransporter 2 (SGLT2) inhibitors
are medications that help lower blood sugar levels by preventing the kidneys from reabsorbing glucose back into the blood. They are primarily used to treat diabetes but are being studied in this trial for their potential benefits on heart health after a heart attack.

What is already known about the treatment

Beta Blockers
These medications are typically administered orally or intravenously and are used to manage heart conditions. They are well-established in medical literature and are commonly prescribed for conditions like myocardial ischemia and myocardial infarction. Beta blockers work by blocking the effects of adrenaline on the heart, which slows the heart rate and reduces blood pressure, helping to decrease the heart's demand for oxygen. They belong to the pharmacological class of beta-adrenergic blocking agents.
Angiotensin Converting Enzyme Inhibitors (ACEI)
These drugs are usually taken orally and are widely used in the treatment of heart-related conditions. They are recognized in medical literature for their role in managing myocardial ischemia and myocardial infarction. ACE inhibitors function by blocking the conversion of angiotensin I to angiotensin II, a substance that narrows blood vessels, thus helping to lower blood pressure and reduce strain on the heart. They are classified as antihypertensive agents.
Sodium/Glucose Cotransporter 2 Inhibitors (SGLT2 Inhibitors)
These medications are generally administered orally and are gaining recognition in the treatment of heart conditions. They are noted in medical literature for their potential benefits in myocardial ischemia and myocardial infarction. SGLT2 inhibitors work by preventing the reabsorption of glucose in the kidneys, leading to its excretion in the urine, which can also have beneficial effects on heart health. They are classified as antidiabetic agents.

Investigated diseases

Myocardial Ischemia
This condition occurs when blood flow to the heart muscle is reduced, often due to a partial or complete blockage of the heart's arteries. It can lead to chest pain, known as angina, and may cause shortness of breath. The heart muscle may not receive enough oxygen, especially during physical exertion or stress. Over time, this reduced blood flow can weaken the heart muscle and affect its ability to pump blood efficiently. If untreated, it can lead to more severe heart conditions.
Myocardial Infarction
Commonly known as a heart attack, this condition happens when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. This blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the coronary arteries. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The severity of the heart attack depends on the size and location of the blockage. Immediate medical attention is crucial to restore blood flow and minimize heart damage.