Idiopathic Recurrent PericarditisPAIReDNCT04996108
Pericarditis: Auto-Inflammation in Recurrent Disease
An observational study of Idiopathic Recurrent Pericarditis, run by King's College London at 2 sites in United Kingdom.
Trial summary
Pericarditis is swelling of the sac that surrounds the heart, the pericardium, causing chest pain. For most patients, the condition improves with simple anti-inflammatory medications like colchicine and ibuprofen. However, in 20-30% of patients the condition comes back. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Recurrent Pericarditis
- How many people
- 119 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 29 Jul 2021to 13 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population for cases comprises patients under the care of the recruiting sites with a diagnosis of RP.
Who may be able to join
- Recurrent pericarditis (RP) cases:
- Patients with RP, diagnosed by a clinician, meeting the European Society of Cardiology (ESC) diagnostic criteria.
- Where the aetiology of the RP is defined as idiopathic (i.e. there is no other aetiology identified, such as infective, malignant, post cardiac injury, as part of an autoimmune condition, as part of another known auto-inflammatory disease).
- Relatives of RP cases:
- First degree relatives of participants meeting the criteria for, and included in the study as, RP cases.
- Disease Controls:
Show all 9Show fewer
- Patients with a systemic auto-inflammatory disease, diagnosed by a trained specialist.
- Healthy Controls:
- Sex, ethnicity and aged matched healthy individuals who do not have a personal history of pericarditis or systemic auto-inflammatory disease.
Who cannot join
- Individuals under 12 years of age
- Adults who are unable to give written informed consent
- Individuals who have received a blood transfusion within 4 weeks
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Free Hospital NHS Foundation Trust
London, NW3 2QG
Claire J Peet, BMBCh MRCP, claire.peet@nhs.net
- Not yet recruiting
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Catherine Smith
About this study
Official title: An Observational Study to Investigate the Auto-inflammatory Basis of Recurrent Pericarditis
Pericarditis is swelling of the sac that surrounds the heart, the pericardium, causing chest pain. For most patients, the condition improves with simple anti-inflammatory medications like colchicine and ibuprofen. However, in 20-30% of patients the condition comes back. Diagnosis of recurrent pericarditis is frequently missed or delayed, and many patients require prolonged courses of corticosteroids to control their disease. Together these factors damage the quality of life of patients with recurrent pericarditis. Currently there is limited understanding of why pericarditis comes back in some patients, and how best to treat it when it does.
PAIReD (Pericarditis: Auto-Inflammation in Recurrent Disease) is an observational research study funded by the British Heart Foundation that will investigate the role inflammation plays in recurrent pericarditis. Patients with recurrent pericarditis and other auto-inflammatory diseases will be recruited from the specialist fever clinic at the Royal Free Hospital, where they will be asked to donate blood up to six times over a three year period. Healthy participants will be recruited at the Royal Free Hospital or Guy's Hospital. Relatives of participants with recurrent pericarditis will be recruited at the Royal Free Hospital. They latter two groups will attend one appointment where blood or saliva samples will be taken. A subset of participants will also provide fingerstick blood samples and questionnaires from home, for up to one year.
Clinical data will be collected prospectively and by retrospective case note review. Blood from participants will be analysed to look at how the immune cells of patients with recurrent pericarditis function during the course of their disease, and to look for genetic changes in patients with recurrent pericarditis that might contribute to their condition. Together this knowledge has to potential to help clinicians diagnose and monitor patients with recurrent pericarditis more accurately, and researchers to design more effective treatments.
- Conditions
- Idiopathic Recurrent 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 |
|---|---|---|
| Participants with recurrent pericarditis (RP) | Patients aged 16 or over with (1) RP, diagnosed by a clinician, meeting the European Society of Cardiology (ESC) diagnostic criteria, and (2) where the aetiology of the RP is defined as idiopathic (i.e. there is no other aetiology identified, such as infective, malignant, post cardiac injury, as part of an autoimmune condition, as part of another known auto-inflammatory disease). | |
| Participants with systemic auto-inflammatory diseases (disease controls) | Patients aged 16 or over with a systemic auto-inflammatory disease, diagnosed by a trained specialist. | |
| Healthy volunteers (healthy controls) | Sex, ethnicity and aged matched healthy individuals who do not have a personal history of pericarditis or systemic auto-inflammatory disease. | |
| Relatives of individuals with recurrent pericarditis (familial controls) | First degree relatives of participants meeting the criteria for, and included in the study as, RP cases, who are aged 16 or over. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune cell phenotype
Exploratory analysis of the proportion, maturity and activation state of different immune cell populations in the peripheral blood, comparing cases and controls and correlated to disease activity in cases
Measured: Three years
Immune cell gene expression
Exploratory analysis of the transcriptome in immune cells in cases compared to controls, and correlated to disease activity in cases.
Measured: Three years
Secondary outcomes (2)
Genotype
Candidate gene analysis and whole exome sequencing of cases and familial controls.
Measured: Three years
Clinical phenotype
Characterisation of clinical course of cohort of RP patients, gathering data on disease activity and quality of life prospectively over three years
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start29 Jul 2021
- Primary completion13 Jun 2024 (estimated)
- Study completion13 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Recurrent 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Claire J Peet, BMBCh MRCP, Principal investigator, Clinical research fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996108
- Sponsor's protocol ID
- 286959
- Acronym
- PAIReD
- Status last verified
- Jul 2021
- First submitted
- 30 Jul 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate the Auto-inflammatory Basis of Recurrent Pericarditis
- ClinicalTrials.gov ID
- NCT04996108
- Acronym / sponsor ID
- PAIReD / 286959
- Conditions
- Idiopathic Recurrent Pericarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Royal Free Hospital NHS Foundation Trust
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 13 Jun 2024 (estimated)
- Study completion
- 13 Jun 2024 (estimated)
- First posted
- 9 Aug 2021 (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.
Pericarditis is swelling of the sac that surrounds the heart, the pericardium, causing chest pain. For most patients, the condition improves with simple anti-inflammatory medications like colchicine and ibuprofen. However, in 20-30% of patients the condition comes back. Diagnosis of recurrent pericarditis is frequently missed or delayed, and many patients require prolonged courses of corticosteroids to control their disease. Together these factors damage the quality of life of patients with recurrent pericarditis. Currently there is limited understanding of why pericarditis comes back in some patients, and how best to treat it when it does.
PAIReD (Pericarditis: Auto-Inflammation in Recurrent Disease) is an observational research study funded by the British Heart Foundation that will investigate the role inflammation plays in recurrent pericarditis. Patients with recurrent pericarditis and other auto-inflammatory diseases will be recruited from the specialist fever clinic at the Royal Free Hospital, where they will be asked to donate blood up to six times over a three year period. Healthy participants will be recruited at the Royal Free Hospital or Guy's Hospital. Relatives of participants with recurrent pericarditis will be recruited at the Royal Free Hospital. They latter two groups will attend one appointment where blood or saliva samples will be taken. A subset of participants will also provide fingerstick blood samples and questionnaires from home, for up to one year.
Clinical data will be collected prospectively and by retrospective case note review. Blood from participants will be analysed to look at how the immune cells of patients with recurrent pericarditis function during the course of their disease, and to look for genetic changes in patients with recurrent pericarditis that might contribute to their condition. Together this knowledge has to potential to help clinicians diagnose and monitor patients with recurrent pericarditis more accurately, and researchers to design more effective treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with recurrent pericarditis (RP) | – | –Patients aged 16 or over with (1) RP, diagnosed by a clinician, meeting the European Society of Cardiology (ESC) diagnostic criteria, and (2) where the aetiology of the RP is defined as idiopathic (i.e. there is no other aetiology identified, such as infective, malignant, post cardiac injury, as part of an autoimmune condition, as part of another known auto-inflammatory disease). |
| Participants with systemic auto-inflammatory diseases (disease controls) | – | –Patients aged 16 or over with a systemic auto-inflammatory disease, diagnosed by a trained specialist. |
| Healthy volunteers (healthy controls) | – | –Sex, ethnicity and aged matched healthy individuals who do not have a personal history of pericarditis or systemic auto-inflammatory disease. |
| Relatives of individuals with recurrent pericarditis (familial controls) | – | –First degree relatives of participants meeting the criteria for, and included in the study as, RP cases, who are aged 16 or over. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population for cases comprises patients under the care of the recruiting sites with a diagnosis of RP.
Key inclusion criteria (9 listed)
- Patients with RP, diagnosed by a clinician, meeting the European Society of Cardiology (ESC) diagnostic criteria.
- Where the aetiology of the RP is defined as idiopathic (i.e. there is no other aetiology identified, such as infective, malignant, post cardiac injury, as part of an autoimmune condition, as part of another known auto-inflammatory disease).
- First degree relatives of participants meeting the criteria for, and included in the study as, RP cases.
- Patients with a systemic auto-inflammatory disease, diagnosed by a trained specialist.
- Sex, ethnicity and aged matched healthy individuals who do not have a personal history of pericarditis or systemic auto-inflammatory disease.
Key exclusion criteria (3 listed)
- Individuals under 12 years of age
- Adults who are unable to give written informed consent
- Individuals who have received a blood transfusion within 4 weeks
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
Immune cell phenotype
Time frame: Three years
Exploratory analysis of the proportion, maturity and activation state of different immune cell populations in the peripheral blood, comparing cases and controls and correlated to disease activity in cases
Immune cell gene expression
Time frame: Three years
Exploratory analysis of the transcriptome in immune cells in cases compared to controls, and correlated to disease activity in cases.
2 secondary outcomes
Genotype
Time frame: Three years
Clinical phenotype
Time frame: Three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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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.
Claire J Peet, BMBCh MRCP principal investigator
Clinical research fellow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Recurrent Pericarditis, run by King's College London at 2 sites in United Kingdom.
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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire J Peet, BMBCh MRCP (02071886412, claire.peet@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune cell phenotype (time frame: Three years). The study lists 2 primary outcomes in all. 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 17 Aug 2021.