NCT04088279

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

2 years

First QC Date

July 31, 2019

Last Update Submit

September 11, 2019

Conditions

Pulmonary Hypertension

Keywords

MRIoxygen enhancedfourier decomposition

Outcome Measures

Primary Outcomes (4)

  • Delta pO2 max (mmHg)

    Baseline and 3-6 months

  • Wash in and wash out time constants (min)

    Baseline and 3-6months

  • Signal Intensity Change (%)

    Baseline and 3-6months

  • Fractions (% area of lung imaged)

    Baseline and 3-6 months

Interventions

MRIDIAGNOSTIC_TEST

Oxygen enhanced and fourier decomposition MRI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed diagnosis of Pulmonary Hypertension.
  • Age 18 and over.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Brompton Hospital

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Simon Padley

    Royal Brompton & Harefield NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrik Pettersson

CONTACT

0330 128 8736p.pettersson@rbht.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

September 12, 2019

Study Start

November 19, 2018

Primary Completion

December 1, 2020

Study Completion

June 1, 2021

Last Updated

September 12, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)