Study on Ibuprofen vs. Conventional Treatment for Patients with Acute Myocarditis

1 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a medication called Ibuprofen in patients with a heart condition known as Acute Myocarditis. Acute Myocarditis is an inflammation of the heart muscle that can affect the heart’s ability to pump blood effectively. The study will compare the use of Ibuprofen, a common non-steroidal anti-inflammatory drug (NSAID), with conventional treatment using another pain reliever, Paracetamol.

The purpose of the study is to determine if Ibuprofen is more effective than Paracetamol in treating Acute Myocarditis, particularly in patients whose heart is still functioning well. Participants will be given either Ibuprofen or Paracetamol for a period of three weeks. The study will monitor changes in the heart over a six-month period using a special imaging technique called Cardiac Magnetic Resonance (CMR), which helps visualize the heart’s structure and function.

Throughout the study, participants will undergo regular check-ups to assess their heart health and any changes in their condition. The goal is to see if Ibuprofen can reduce the inflammation in the heart more effectively than the conventional treatment. This research aims to provide valuable insights into better treatment options for those affected by Acute Myocarditis.

1 joining the study

Participation begins after meeting the inclusion criteria: being 18 years or older, hospitalized for confirmed acute myocarditis with a left ventricular ejection fraction of 50% or more, absence of acute heart failure, exclusion of ischemic heart disease, and ability to provide informed consent.

2 initial assessment

An initial cardiac magnetic resonance imaging (MRI) is performed to confirm the diagnosis of acute myocarditis and to establish a baseline for late gadolinium enhancement, which is a measure used to assess heart tissue damage.

3 treatment phase

Participants are randomly assigned to one of two treatment groups. One group receives ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), administered orally. The dosage and frequency are determined by the study protocol and are taken for a duration of 3 weeks.

The other group receives conventional treatment with analgesics, specifically paracetamol, also administered orally, following the same duration of 3 weeks.

4 follow-up assessments

Participants undergo regular follow-up assessments to monitor their health status and any changes in symptoms. These assessments are scheduled according to the study protocol.

5 final assessment

At 6 months after the initial diagnosis, a follow-up cardiac MRI is conducted to measure changes in late gadolinium enhancement compared to the baseline. This helps to evaluate the effectiveness of the treatment in reducing heart tissue damage.

Who Can Join the Study?

  • Must be 18 years or older.
  • Must be hospitalized for confirmed acute myocarditis, which is an inflammation of the heart muscle.
  • Must have a left ventricular ejection fraction of 50% or higher. This is a measure of how well the heart is pumping blood.
  • Must not have acute heart failure, which is when the heart suddenly can’t pump enough blood to meet the body’s needs.
  • Must not have ischemic heart disease, which is a condition caused by narrowed heart arteries.
  • Must meet the diagnostic criteria for myocarditis using a special heart scan called cardiac magnetic resonance imaging.
  • Must be able to provide informed consent, meaning you understand the study and agree to participate.

Who Cannot Join the Study?

  • Patients with other heart conditions that are not related to acute myocarditis cannot participate. Acute myocarditis is a condition where the heart muscle becomes inflamed.
  • Individuals who have had a recent heart attack or other serious heart events are excluded.
  • Patients with severe kidney or liver disease are not eligible.
  • People who are currently taking medications that might interfere with the study treatment cannot join.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Individuals with a history of allergic reactions to ibuprofen or paracetamol are excluded.
  • Participants in another clinical trial at the same time are not eligible.
  • Anyone with a condition that the study doctors believe would make it unsafe for them to participate will be excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Salamanca Salamanca Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Severo Ochoa Leganes Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Area De Salud De Burgos Y Soria Burgos Spain
Hhmvtdua Dh Lc Syzjj Ckps I Siye Ppe Barcelona Spain
Hrbamkyz Vsje dyhnazyd Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.09.2024

Trial locations

Investigated drugs:

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) used in this trial to see if it can help reduce inflammation in the heart muscle for patients with acute myocarditis. The study aims to determine if taking ibuprofen for three weeks can improve heart health by reducing certain markers seen in heart imaging tests.

Paracetamol is a common pain reliever and fever reducer used as a conventional treatment in this trial. It is being compared to ibuprofen to see which is more effective in managing symptoms and improving heart health in patients with acute myocarditis.

Acute myocarditis – Acute myocarditis is an inflammation of the heart muscle, often caused by viral infections, autoimmune diseases, or exposure to certain toxins. It can lead to symptoms such as chest pain, fatigue, shortness of breath, and irregular heartbeats. The inflammation can disrupt the heart’s ability to pump blood effectively, potentially causing fluid buildup in the lungs or other parts of the body. In some cases, the condition may resolve on its own, while in others, it can progress to more severe heart problems. The severity and progression of symptoms can vary widely among individuals. Monitoring and supportive care are often necessary to manage the condition.

Trial ID:
2024-513803-15-00
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Colchicine for Reducing Heart Damage in Patients with Acute Myocarditis

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France
  • Study of prednisone and azathioprine treatment in patients with virus-negative myocarditis or inflammatory heart muscle disease with reduced heart pump function

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland