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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088279
• Other study ID #: 246688
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: June 2021

Study information

• Verified date: September 2019
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: Patrik Pettersson
• Phone: 0330 128 8736
• Email: p.pettersson[@]rbht.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Diagnostic Test:
• MRI
Oxygen enhanced and fourier decomposition MRI

Locations

Country	Name	City	State
United Kingdom	Royal Brompton Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta pO2 max (mmHg)		Baseline and 3-6 months
Primary	Wash in and wash out time constants (min)		Baseline and 3-6months
Primary	Signal Intensity Change (%)		Baseline and 3-6months
Primary	Fractions (% area of lung imaged)		Baseline and 3-6 months