PericarditisNCT06517966
RUDRA Registry (Real-World Clinical Registry for Patients With Recurrent Pericarditis)
An observational study of Pericarditis, run by Eurasian Association of Therapists at 1 site in Russia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pericarditis
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 30 Sep 2024to 30 Nov 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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"
Who may be able to join
- 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".
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
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.
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.
- Conditions
- Pericarditis
- Medical subject headings
- Pericarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6, 12, 18, 24, 30, 36 month
Secondary outcomes (10)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 0, 12, 24, 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start30 Sep 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PericarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Eurasian Association of Therapists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517966
- Sponsor's protocol ID
- RUDRA
- Status last verified
- Sep 2026
- First submitted
- 15 Jul 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RUDRA Registry (Real-World Clinical Registry for Patients With Recurrent Pericarditis)
- ClinicalTrials.gov ID
- NCT06517966
- Acronym / sponsor ID
- RUDRA
- Conditions
- Pericarditis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Eurasian Association of TherapistsUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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"
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
10 secondary outcomes
Number of participants with therapy changes during the past period
Time frame: 6, 12, 18, 24, 30, 36 month
Hospitalization for any reason
Time frame: 6, 12, 18, 24, 30, 36 month
Hospitalization due to pericarditis
Time frame: 6, 12, 18, 24, 30, 36 month
Hospitalization for another cardiac cause
Time frame: 6, 12, 18, 24, 30, 36 month
Death from any cause
Time frame: 6, 12, 18, 24, 30, 36 month
Death due to cardiac cause
Time frame: 6, 12, 18, 24, 30, 36 month
Cardiovascular events (STEMI, MI, TIA, etc.)
Time frame: 6, 12, 18, 24, 30, 36 month
Development of complications of recurrent pericarditis (constrictive pericarditis, cardiac tamponade, etc.)
Time frame: 6, 12, 18, 24, 30, 36 month
Quality of life (prospective branch only)
Time frame: 0, 12, 24, 36 month
Pain scale (prospective branch only)
Time frame: 0, 12, 24, 36 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pericarditis, run by Eurasian Association of Therapists at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pericarditis recurrences (time frame: 6, 12, 18, 24, 30, 36 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.