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NCT Number: NCT06517966

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Eurasian Association of Therapists

Moscow, 11000, Russia

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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

  • Age below 18 years at the time of inclusion in the registry or debut of pericarditis;
  • 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;
  • Organ/tissue transplantation less than 5 years prior to study inclusion or debut of pericarditis;
  • Oncologic disease less than 3 years prior to study inclusion or pericarditis debut;
  • Chemotherapy with anthracycline-type drugs at the time of pericarditis debut;
  • Administration of amphetamine-type drugs at the time of pericarditis debut;
  • Cardiac/pericardial surgery in the last 6 months prior to study inclusion or pericarditis debut;
  • Myocardial infarction in the last 3 months prior to study inclusion or debut of pericarditis;
  • Traumatic chest injury in the last 3 months prior to study inclusion or pericarditis debut;
  • Absence of an informed consent form signed by the patient for participation in the study

Treatment and study plan

Primary outcomes

  1. Number of pericarditis recurrences

    Time frame: 6, 12, 18, 24, 30, 36 month

    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

Secondary outcomes

  1. Number of participants with therapy changes during the past period

    Time frame: 6, 12, 18, 24, 30, 36 month

    Determining therapy changes in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)

  2. Hospitalization for any reason

    Time frame: 6, 12, 18, 24, 30, 36 month

    To estimate hospitalization for any reason at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis

  3. Hospitalization due to pericarditis

    Time frame: 6, 12, 18, 24, 30, 36 month

    To estimate hospitalization due to pericarditis at each visit (6, 12, 18, 24, 30, 36 month) in a cohort of patients with recurrent pericarditis

  4. Hospitalization for another cardiac cause

    Time frame: 6, 12, 18, 24, 30, 36 month

    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

  5. Death from any cause

    Time frame: 6, 12, 18, 24, 30, 36 month

    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. Death due to cardiac cause

    Time frame: 6, 12, 18, 24, 30, 36 month

    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

  7. Cardiovascular events (STEMI, MI, TIA, etc.)

    Time frame: 6, 12, 18, 24, 30, 36 month

    To assess the development of cardiovascular events in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)

  8. Development of complications of recurrent pericarditis (constrictive pericarditis, cardiac tamponade, etc.)

    Time frame: 6, 12, 18, 24, 30, 36 month

    To assess the development of complications of recurrent pericarditis in patients with recurrent pericarditis at each visit (6, 12, 18, 24, 30, 36 month)

  9. Quality of life (prospective branch only)

    Time frame: 0, 12, 24, 36 month

    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.

  10. Pain scale (prospective branch only)

    Time frame: 0, 12, 24, 36 month

    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.

Sponsors and collaborators

Lead sponsor

Eurasian Association of Therapists

Other

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jul 24, 2024
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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