Clinical trial NCT06517966: RUDRA Registry (Real-World Clinical Registry for Patients With Recurrent Pericarditis)
Official title: RUDRA Registry (Real-World Clinical Registry for Patients With Recurrent Pericarditis)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pericarditis
Lead sponsor: Eurasian Association of Therapists
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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"

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.

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.

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

Primary outcomes:
measure: Number of pericarditis recurrences
timeFrame: 6, 12, 18, 24, 30, 36 month
Secondary outcomes:
measure: Number of participants with therapy changes during the past period
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Hospitalization for any reason
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Hospitalization due to pericarditis
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Hospitalization for another cardiac cause
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Death from any cause
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Death due to cardiac cause
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Cardiovascular events (STEMI, MI, TIA, etc.)
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Development of complications of recurrent pericarditis (constrictive pericarditis, cardiac tamponade, etc.)
timeFrame: 6, 12, 18, 24, 30, 36 month
measure: Quality of life (prospective branch only)
timeFrame: 0, 12, 24, 36 month
measure: Pain scale (prospective branch only)
timeFrame: 0, 12, 24, 36 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Eurasian Association of Therapists
Study officials:
References: