CASPA: CArdiac Sarcoidosis in PApworth (NCT03599414) | Clinical Trial Compass
CompletedNot Applicable
CASPA: CArdiac Sarcoidosis in PApworth
United Kingdom104 participantsStarted 2017-06-29
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis