CASPA: CArdiac Sarcoidosis in PApworth

Interstitial Lung Disease Clinical Trial

— CASPA  

Official title:

CASPA (CArdiac Sarcoidosis in PApworth): Improving the Diagnosis of Cardiac Disease in Patients With Pulmonary Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599414
• Other study ID #: P02262
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: March 8, 2023

Study information

• Verified date: June 2023
• Source: Papworth Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 8, 2023
• Est. primary completion date: March 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Sarcoidosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Locations

Country	Name	City	State
United Kingdom	Royal Papworth Hospital	Papworth Everard	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis	The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis	on Day 1
Secondary	Cytokine and Proteomic profiling	Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis	after 1 year
Secondary	Diagnosis of cardiac sarcoidosis	Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring	on Day 1