## Protocol Section
### Identification Module
**NCT ID:** NCT04088279

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

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

#### Organization Study ID Info
**ID:** 246688
#### Organization
**Class:** OTHER
**Full Name:** Royal Brompton & Harefield NHS Foundation Trust
### Status Module
#### Completion Date
**Date:** 2021-06

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2019-09-12

**Type:** ACTUAL

**Last Update Submit Date:** 2019-09-11

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2020-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-11-19

**Type:** ACTUAL

**Status Verified Date:** 2019-09

#### Study First Post Date
**Date:** 2019-09-12
**Type:** ACTUAL
**Study First Submit Date:** 2019-07-31
**Study First Submit QC Date:** 2019-09-11
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Royal Brompton & Harefield NHS Foundation Trust

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pulmonary Hypertension

**Keywords:**

- MRI

- oxygen enhanced

- fourier decomposition

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Oxygen enhanced and fourier decomposition MRI

**Name:** MRI

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Measure:** Delta pO2 max (mmHg)

**Time Frame:** Baseline and 3-6 months

**Measure:** Wash in and wash out time constants (min)

**Time Frame:** Baseline and 3-6months

**Measure:** Signal Intensity Change (%)

**Time Frame:** Baseline and 3-6months

**Measure:** Fractions (% area of lung imaged)

**Time Frame:** Baseline and 3-6 months

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** p.pettersson@rbht.nhs.uk

**Name:** Patrik Pettersson

**Phone:** 0330 128 8736

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** s.sathianandan@nhs.net

- **Name:** Sobi Sathianandan, MBBS

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** Royal Brompton Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Royal Brompton & Harefield NHS Foundation Trust

**Name:** Simon Padley

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Hypertension

- ID: M10027

- Name: Hypertension, Pulmonary

- Relevance: HIGH

- As Found: Pulmonary Hypertension

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006976

- Term: Hypertension, Pulmonary

- ID: D000006973

- Term: Hypertension

### Misc Info Module

- Version Holder: 2024-05-24
