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

А multicenter, non-interventional real world clinical registry of patients with recurrent pericarditis.

The main goal of the registry is to epidemiologically assess the pattern, clinical outcomes, and approaches to therapy in patients with recurrent pericarditis.

Study Overview

• Status: Active, not recruiting
• Conditions: Pericarditis

Detailed Description

А multicenter, non-interventional real world clinical registry of patients with recurrent pericarditis.

The main goal of the registry is to epidemiologically assess the pattern, clinical outcomes, and approaches to therapy in patients with recurrent pericarditis.

This goal can best be achieved through a registry of real clinical practice. Epidemiologic assessment of the structure will be possible due to the retrospective part of the registry and will give an idea of the etiology of RP in the Russian Federation, as well as allow to identify a subpopulation of patients with idiopathic recurrent pericarditis and study it in more detail. The prospective branch involves three-year dynamic follow-up of patients with already diagnosed and newly diagnosed IRP. Based on the data obtained during the retro- and prospective parts of the registry, it will be possible to evaluate clinical outcomes and approaches to therapy in patients with recurrent pericarditis, which may become valuable material for assessing the real clinical situation in the Russian Federation, as well as deepen knowledge on the diagnosis and management of this cohort of patients.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 11000
    • Eurasian Association of Therapists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Anonymous male and female patients over 18 years of age suffering from recurrent pericarditis without an established etiology at the time of inclusion in the study (suspected "idiopathic recurrent pericarditis") or diagnosed with "idiopathic recurrent pericarditis"

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Retrospective branch; All patients diagnosed with recurrent pericarditis within the previous 10 years (of any genesis) were included.
Prospective branch; All patients with one of the following conditions were included: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pericarditis recurrences	according to the 2022 nation criteria: intermittent or intermittent (with asymptomatic periods without the use of therapy for more than 6 weeks); continuous-relapsing (discontinuation or reduction in the intensity of anti-inflammatory therapy results in relapse in less than 6 weeks	6, 12, 18, 24, 30, 36 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with therapy changes during the past period	Determining therapy changes in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)	6, 12, 18, 24, 30, 36 month
Hospitalization for any reason	To estimate hospitalization for any reason at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis	6, 12, 18, 24, 30, 36 month
Hospitalization due to pericarditis	To estimate hospitalization due to pericarditis at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis	6, 12, 18, 24, 30, 36 month
Hospitalization for another cardiac cause	To estimate hospitalization for another cardiac cause at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis	6, 12, 18, 24, 30, 36 month
Death from any cause	To estimate death from any cause at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis	6, 12, 18, 24, 30, 36 month
Death due to cardiac cause	To estimate death due to cardiac cause at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis	6, 12, 18, 24, 30, 36 month
Cardiovascular events (STEMI, MI, TIA, etc.)	To assess the development of cardiovascular events in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)	6, 12, 18, 24, 30, 36 month
Development of complications of recurrent pericarditis (constrictive pericarditis, cardiac tamponade, etc.)	To assess the development of complications of recurrent pericarditis in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)	6, 12, 18, 24, 30, 36 month
Quality of life (prospective branch only)	To assess the quality of life of patients with recurrent pericarditis. The quality of life will be assessed using the SF-12 short form, consisting of 12 questions. A low quality of life corresponds to scores of 36-47 points, medium to 24-35 points, and high to 12-23 points.	0, 12, 24, 36 month
Pain scale (prospective branch only)	To assess the level of pain (on a pain scale) of patients with recurrent pericarditis. The pain syndrome will be assessed using the Visual Analog Scale, where 10 points indicate unbearable pain and 0 points indicate no pain.	0, 12, 24, 36 month

Collaborators and Investigators

• Sponsor: Eurasian Association of Therapists

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): November 1, 2028

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Pericarditis
• Other Study ID Numbers: RUDRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No