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Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)

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ClinicalTrials.gov Identifier: NCT04088279
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Diagnostic Test: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Novel Quantitative Magnetic Resonance Imaging (MRI) Measures in the Assessment and Follow-up of Patients With Pulmonary Hypertension (PH)
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: MRI
    Oxygen enhanced and fourier decomposition MRI


Primary Outcome Measures :
  1. Delta pO2 max (mmHg) [ Time Frame: Baseline and 3-6 months ]
  2. Wash in and wash out time constants (min) [ Time Frame: Baseline and 3-6months ]
  3. Signal Intensity Change (%) [ Time Frame: Baseline and 3-6months ]
  4. Fractions (% area of lung imaged) [ Time Frame: Baseline and 3-6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088279


Contacts
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Contact: Patrik Pettersson 0330 128 8736 p.pettersson@rbht.nhs.uk

Locations
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United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom
Contact: Sobi Sathianandan, MBBS       s.sathianandan@nhs.net   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Principal Investigator: Simon Padley Royal Brompton & Harefield NHS Foundation Trust

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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04088279     History of Changes
Other Study ID Numbers: 246688
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: September 12, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
MRI
oxygen enhanced
fourier decomposition
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases