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

NCT06517966 | Active Not Recruiting

• 1 other identifier: RUDRA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pericarditis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Number of participants with therapy changes during the past period

  6, 12, 18, 24, 30, 36 month

• Hospitalization for any reason

  6, 12, 18, 24, 30, 36 month

• Hospitalization due to pericarditis

  6, 12, 18, 24, 30, 36 month

• Hospitalization for another cardiac cause

  6, 12, 18, 24, 30, 36 month

• Death from any cause

  6, 12, 18, 24, 30, 36 month

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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"

You may qualify if:

• Men or women 18 years of age or older at the time of data recording or pericarditis debut;
• Presence of one of the following conditions:
• a specialist-confirmed diagnosis of "idiopathic recurrent pericarditis".

You may not qualify if:

• 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.);
• lack of possibility of screening examination and dynamic follow-up;
• Chemotherapy with anthracycline-type drugs at the time of pericarditis debut;
• Administration of amphetamine-type drugs at the time of pericarditis debut;
• Absence of an informed consent form signed by the patient for participation in the study

Sponsors & Collaborators

• Eurasian Association of Therapists: lead

Study Sites (1)

Eurasian Association of Therapists

Moscow, 11000, Russia

Location

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 24, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)