- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088279
Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
September 11, 2019 updated by: Royal Brompton & Harefield NHS Foundation Trust
A prospective study of the use of two novel MRI techniques (oxygen-enhanced and fourier decomposition MRI) in the initial diagnosis and follow-up of patients with Pulmonary Hypertension.
The investigators believe these techniques may present a novel set of imaging biomarkers that may be used for risk stratification, prediction of treatment response and longitudinal disease monitoring.
The reserach MRI is in addition to standard of care and will not affect treatment decisions.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Patrik Pettersson
- Phone Number: 0330 128 8736
- Email: p.pettersson@rbht.nhs.uk
Study Locations
-
-
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London, United Kingdom
- Recruiting
- Royal Brompton Hospital
-
Contact:
- Sobi Sathianandan, MBBS
- Email: s.sathianandan@nhs.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of Pulmonary Hypertension.
- Age 18 and over.
Exclusion Criteria:
- Standard contra-indications to MRI (as per NHS MRI safety questionnaire).
- Not medically fit for transfer to MRI.
- Patient judged inappropriate for involvement in study by clinical team e.g. secondary to emotional burden of recent diagnosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Delta pO2 max (mmHg)
Time Frame: Baseline and 3-6 months
|
Baseline and 3-6 months
|
Wash in and wash out time constants (min)
Time Frame: Baseline and 3-6months
|
Baseline and 3-6months
|
Signal Intensity Change (%)
Time Frame: Baseline and 3-6months
|
Baseline and 3-6months
|
Fractions (% area of lung imaged)
Time Frame: Baseline and 3-6 months
|
Baseline and 3-6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Simon Padley, Royal Brompton & Harefield NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 19, 2018
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
July 31, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 12, 2019
Study Record Updates
Last Update Posted (Actual)
September 12, 2019
Last Update Submitted That Met QC Criteria
September 11, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 246688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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