Skip to main content
OpenTrials
Completed

NCT Number: NCT03599414

CASPA: CArdiac Sarcoidosis in PApworth

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Interstitial Lung Disease Cardiac Sarcoidosis Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Pulmonary Sarcoidosis Respiratory Tract Diseases Sarcoidosis Sarcoidosis, Pulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Papworth Hospital

Papworth Everard, Cambridgeshire, CB23 3RE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

    Time frame: on Day 1

    The prevalence of cardiac sarcoidosis in patients with pulmonary sarcoidosis

Secondary outcomes

  1. Cytokine and Proteomic profiling

    Time frame: after 1 year

    Completion of cytokine and proteomic profiling of patients with pulmonary sarcoidosis

  2. Diagnosis of cardiac sarcoidosis

    Time frame: on Day 1

    Diagnosis of cardiac sarcoidosis by combining signal averaged ECG, speckle tracking echocardiography and 24 hour holter monitoring

Sponsors and collaborators

Lead sponsor

Papworth Hospital NHS Foundation Trust

Other Gov

Collaborators

  • Imperial College London

Registry information

Official study title

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

Acronym: CASPA

Important dates

Study start
2017
Primary completion
2020
Study completion
2023
First posted
Jul 26, 2018
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.