Pericarditis: Auto-Inflammation in Recurrent Disease

NCT04996108 | Unknown

• 1 other identifier: 286959
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 2

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Three years

Secondary Outcomes (2)

• Genotype

  Three years

• Clinical phenotype

  Three years

Study Arms (4)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population for cases comprises patients under the care of the recruiting sites with a diagnosis of RP.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator

Study Sites (2)

Royal Free Hospital NHS Foundation Trust

London, NW3 2QG, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

NOT YET RECRUITING

Study Officials

• Claire J Peet, BMBCh MRCP

  Clinical research fellow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire J Peet, BMBCh MRCP

CONTACT

02071886412; claire.peet@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 9, 2021
• Study Start: July 29, 2021
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: August 17, 2021

Record last verified: 2021-07

Locations

GB (2)