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Active, not recruitingNCT06517966Updated Sep 10, 2026

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

An observational study in Pericarditis, sponsored by Eurasian Association of Therapists. Active, not recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Eurasian Association of Therapists · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pericarditis

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03

In context

Pericarditis

54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's planned enrollment of 100 is below the median of 300 across 25 observational studies indexed under Pericarditis.

Browse Pericarditis studies →

Lead sponsor

Eurasian Association of Therapists is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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"

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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 form signed by the patient for participation in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
100 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

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

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

Secondary outcomes

  1. 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)

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. 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

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

  7. 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)

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

  8. 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)

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

  9. 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.

    Time frame: 0, 12, 24, 36 month

  10. 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.

    Time frame: 0, 12, 24, 36 month

07

Study locations

1 site
  • Eurasian Association of Therapists
    Moscow, 11000, Russia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2024 (actual). Primary completion is estimated for Jul 2027, 34 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2024
First posted
Jul 24, 2024
StartActual
Sep 30, 2024
Primary completionEst.
Jul 30, 2027
CompletionEst.
Nov 30, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06517966
Lead sponsor
Eurasian Association of Therapists
Responsible party
Sponsor
First posted
Jul 24, 2024
Start date
Sep 30, 2024
Primary completion
Jul 30, 2027 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
Sep 10, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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