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CASPA: CArdiac Sarcoidosis in PApworth

Study Purpose

Sarcoidosis is a disease of unknown cause which affects adults of all ethnic backgrounds. Clumps of tissue called granulomas develop primarily in the lungs, but can damage other organs, especially the heart. Anecdotal evidence from autopsy studies suggests the heart is affected in up to 68% of patients, but there is much uncertainty about this figure. If undetected and untreated, it can lead to serious complications or even sudden death. The current recommendation is to perform heart tracings (ECG s) on all patients, but this detects fewer than half of those with heart involvement. Blood markers traditionally used to diagnose heart disease are unreliable, meaning there is no simple blood test in use. The investigators propose a study with three aims. Firstly, identify the true prevalence of heart disease by performing Magnetic Resonance Imaging (MRI) scans on a group of patients with newly diagnosed lung sarcoidosis. Those found to have heart disease will have specialist (but routine) electrical heart tests. Secondly, (and perhaps the most immediate and clinically relevant) to identify the best method of diagnosing heart involvement using a combination of three simple tests: advanced ECG, 24-hour continuous ECG and a new type of computerised ultrasound scan. Thirdly, to identify proteins in the blood that could be used to develop a simple blood test for heart involvement in patients with lung sarcoidosis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Newly referred adult patients with pulmonary sarcoidosis and diagnosis made at multidisciplinary meeting as per current joint BTS/ATS guidance.

- Patient may be on ≤10mg prednisolone at time of recruitment (if already started at another site prior to referral).

- Able to give informed consent and able to comply with protocol.

- ≥>18 yrs.

Exclusion Criteria:

- History of other cardiac disease (e.g. coronary artery disease)cardiac surgery or previous myocardial infarction (MI) - Inability to give informed consent.

- <18 yrs.

- Patient may be on >10mg prednisolone at time of recruitment (if already started at another site prior to referral).

- On non-steroidal medication including methotrexate.

- Pregnancy.

- Alcoholism.

- Illicit drug abuse.

Exclusion criteria for MRI:

- Cardiac pacemakers.

- Surgical clips in the head (particularly aneurysm clips) - Electronic inner ear implants (bionic ears) - Ocular metal fragments • Electronic stimulators • Implanted pumps.

- Severe claustrophobia

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03599414
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Papworth Hospital NHS Foundation Trust
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Muhunthan Thillai
Principal Investigator Affiliation	Royal Papworth Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease, Pulmonary Sarcoidosis, Cardiac Sarcoidosis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.