An observational study in Idiopathic Recurrent Pericarditis, sponsored by King's College London. Status unknown at 2 sites in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by King's College London · Observational
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.
54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.
This study's planned enrollment of 119 is below the median of 300 across 25 observational studies indexed under Pericarditis.
Browse Pericarditis studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Study population for cases comprises patients under the care of the recruiting sites with a diagnosis of RP.
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.
Recurrent pericarditis (RP) cases:
Relatives of RP cases:
First degree relatives of participants meeting the criteria for, and included in the study as, RP cases.
Disease Controls:
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.
Exclusion Criteria:
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Patients aged 16 or over 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.
First degree relatives of participants meeting the criteria for, and included in the study as, RP cases, who are aged 16 or over.
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
Time frame: 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.
Time frame: Three years
Genotype
Candidate gene analysis and whole exome sequencing of cases and familial controls.
Time frame: 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
Time frame: Three years
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.