Bisoprolol for pericarditis -Phase III randomized controlled clinical trial in patients with acute or recurrent pericarditis

The primary objective of this study is to evaluate the effectiveness of beta-blocking therapy with **bisoprolol** in reducing the persistence of **pericarditis** symptoms at 2 and 4 weeks and the frequency of relapses at 12 months. This objective addresses the clinical need for improved management strategies in patients with acute or recurrent pericarditis, focusing on symptom control and prevention of disease recurrence.

The secondary objectives include:

• Assessment of symptom persistence at 1 month

• Evaluation of relapse frequency at 12 months

• Analysis of the correlation between baseline **C-reactive protein** values and **heart rate** at first observation

The sponsor did not provide information regarding the total number of participants enrolled in this clinical trial. The study population consists of adult patients diagnosed with acute or recurrent **pericarditis** of any etiology, enrolled within 48 hours of symptom onset. Both **male** and **female** subjects are eligible for participation. The trial includes adults aged 18 years and older, with no upper age limit specified. Principal inclusion criteria require patients to have acute or recurrent pericarditis of any aetiology presenting within 48 hours of symptom onset, to be over 18 years of age, and to provide informed consent with willingness to adhere to study procedures. No vulnerable populations are included in this trial. The sponsor did not provide specific information regarding lifestyle considerations such as diet, physical activity, or habits relevant to the study population.

This is a **Phase III randomized controlled clinical trial** evaluating the effectiveness of **bisoprolol** in patients with **acute or recurrent pericarditis**. The study aims to assess whether beta-blocking therapy with bisoprolol reduces the persistence of pericarditis symptoms at 2 and 4 weeks and decreases the frequency of relapses at 12 months. The trial is classified as a **low-intervention clinical trial** investigating the use of bisoprolol in cases of pericarditis, acute pericarditis, and recurrent pericarditis.

The **primary endpoint** focuses on evaluating the effectiveness of bisoprolol therapy in reducing symptom persistence at 2 and 4 weeks and the frequency of relapses at 12 months. **Secondary endpoints** include the persistence of symptoms at 1 month and the frequency of relapses at 12 months. An additional secondary analysis will examine the correlation between baseline **C-reactive protein** values and heart rate at the first observation.

Eligible participants must meet the following **principal inclusion criteria**: diagnosis of acute or recurrent pericarditis of any etiology within 48 hours of symptom onset, age greater than 18 years, and provision of informed consent with willingness to follow study procedures. The trial involves the administration of bisoprolol as a **tablet** for **oral use**, with a maximum daily dose of **1.25 mg** and a maximum total dose of **1.25 mg**. The maximum treatment period is **28 days**.

The estimated recruitment start date is October 1, 2025, with an estimated study completion date of January 2, 2027. The overall trial duration spans approximately 15 months from the initiation of recruitment to the end of the study. Participant involvement includes screening to confirm eligibility, followed by treatment administration and follow-up visits to assess symptom persistence and relapse occurrence at specified time points including 2 weeks, 4 weeks, 1 month, and 12 months. Conditions that may lead to early termination from the study were not explicitly specified in the available data.

The experimental treatment under investigation consists of **bisoprolol**, a synthetic molecule administered as a **tablet** for **oral use**. The **pharmaceutical form** is a tablet containing bisoprolol as the **active substance**, which is of chemical origin. The **maximum daily dose** is **1.25 mg**, with a **maximum total dose** of **1.25 mg** per administration. The **treatment period** extends for **28 days**. Bisoprolol serves as the test product in this **Phase III randomized controlled clinical trial** evaluating its effectiveness in reducing the persistence of **pericarditis** symptoms at 2 and 4 weeks and decreasing the frequency of relapses at 12 months in patients with **acute or recurrent pericarditis**.

Efficacy will be assessed by evaluating the reduction in persistence of **pericarditis** symptoms at 2 and 4 weeks, as well as the frequency of relapses at 12 months following treatment with **bisoprolol**. The primary endpoints focus on symptom persistence at these specific timepoints and the recurrence rate over the 12-month follow-up period. Secondary endpoints include the persistence of symptoms at 1 month and the frequency of relapses at 12 months. An additional secondary analysis will examine the correlation between baseline **C-reactive protein** values and heart rate at the first observation. The study aims to determine the effectiveness of beta-blocking therapy in reducing symptom duration and preventing disease recurrence in patients with acute or recurrent pericarditis.