PFF Clinical Trial Finder

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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
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

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.

Trial ID:
NCT03599414

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.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Papworth Hospital NHS Foundation Trust

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Muhunthan Thillai
Principal Investigator Affiliation Royal Papworth Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
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.

International Sites

Royal Papworth Hospital, Papworth Everard, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Royal Papworth Hospital

Papworth Everard, Cambridgeshire, CB23 3RE

Site Contact

Victoria Stoneman, PhD

victoria.stoneman@nhs.net

01223639865

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

Back to Top
footer_txt_bblBook a PFF Ambassador for your event.   Call 844.TalkPFF >