NAPUH0003 (CIPHER-MRI)
Research type
Research Study
Full title
A Prospective Multicenter Study for the Assessment of Biomarker Signatures for the Diagnosis of Pulmonary Hypertension (PH) in Patients at Low or Intermediate Probability of PH undergoing Cardiac Magnetic Resonance Imaging (MRI).
IRAS ID
281713
Contact name
David Kiely
Contact email
Sponsor organisation
Janssen-Cilag International NV
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Clinicaltrials.gov, NCT04480723
Duration of Study in the UK
1 years, 4 months, 4 days
Research summary
Patients with PH often have symptoms for many years before a diagnosis is made. Non-invasive methods for diagnosis are needed to help these patients. This is a clinical study designed to collect blood samples for the discovery and development of biomarker signatures to assist in the earlier diagnosis of PH. Participants are to be managed by clinicians per their standard practice for patient care. \n\nThe study will enroll patients who have suspicion of PH and have completed an echocardiogram (scan) of their heart. Based on the results of this scans these patients would be considered not to have PH or have low to medium chance of having PH. These patients would not have undergone an invasive procedure such as Right Heart Catheterization (RHC).\n\nAt time of enrollment patients would give blood samples and undergo an MRI scan of their heart within 6 weeks. The MRI scan will help evaluate if patients have presence of PH, especially in patients who were classed as having low to medium chance of PH based on their echocardiogram scans. The outcome of the MRI evaluation will be provided to the treating physician/ study investigator who may refer the patient for RHC if clinically indicated. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0085
Date of REC Opinion
31 Jul 2020
REC opinion
Favourable Opinion