Registry for patients with recurrent pericarditis

RUDRA Registry (Real-World Clinical Registry for Patients With Recurrent Pericarditis)

This study is collecting information from patients with recurrent pericarditis to see how common it is and how different treatments work over three years.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Eurasian Association of Therapists (Academic / other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Moscow)
• Trial ID: NCT06517966 on ClinicalTrials.gov

What this trial studies

This is a multicenter, non-interventional clinical registry aimed at assessing the epidemiology, clinical outcomes, and treatment approaches for patients with recurrent pericarditis. The registry will include both retrospective and prospective data collection, allowing for a comprehensive understanding of the condition in the Russian Federation. It will focus on identifying idiopathic recurrent pericarditis cases and evaluating their management over a three-year follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a specialist-confirmed diagnosis of recurrent pericarditis, particularly those with idiopathic cases.

Not a fit: Patients with recurrent pericarditis of secondary origin or those under 18 years old will not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance understanding and treatment of recurrent pericarditis, leading to improved patient outcomes.

How similar studies have performed: While similar registries have been conducted, this specific approach focusing on recurrent pericarditis in the Russian context may provide novel insights.

Eligibility criteria

Inclusion Criteria:

1. Men or women 18 years of age or older at the time of data recording or pericarditis debut;
2. Presence of one of the following conditions:

   * a specialist-confirmed diagnosis of recurrent pericarditis without an established etiology at the time of inclusion in the study (suspected "idiopathic recurrent pericarditis");
   * a specialist-confirmed diagnosis of "idiopathic recurrent pericarditis".

Exclusion Criteria:

1. Age below 18 years at the time of inclusion in the registry or debut of pericarditis;
2. Specialist-confirmed secondary genesis of RP (infectious, autoimmune, neoplastic, metabolic, traumatic, iatrogenic, etc.); 2. Manifestations and complications of myocarditis, various diseases of thoracic organs, systemic diseases, cardiac surgery, radiation therapy, tuberculosis, etc.);
3. lack of possibility of screening examination and dynamic follow-up;
4. Organ/tissue transplantation less than 5 years prior to study inclusion or debut of pericarditis;
5. Oncologic disease less than 3 years prior to study inclusion or pericarditis debut;
6. Chemotherapy with anthracycline-type drugs at the time of pericarditis debut;
7. Administration of amphetamine-type drugs at the time of pericarditis debut;
8. Cardiac/pericardial surgery in the last 6 months prior to study inclusion or pericarditis debut;
9. Myocardial infarction in the last 3 months prior to study inclusion or debut of pericarditis;
10. Traumatic chest injury in the last 3 months prior to study inclusion or pericarditis debut;
11. Absence of an informed consent form signed by the patient for participation in the study

Where this trial is running

Moscow

• Eurasian Association of Therapists — Moscow, Russian Federation (Recruiting)

Study contacts

• Study coordinator: Aleksandr Arutiunov, PhD

Conditions Pericarditis