NCT02026531

Brief Summary

The diagnosis of a patient with pulmonary hypertension (PH) requires many investigations. At present cardiac catheterisation is the cornerstone investigation in these patients where it is used to establish disease severity and estimate prognosis. It is an invasive procedure which is expensive and not without risk to the patient. Despite the multitude of tests performed, identifying those patients with PH who have a poor diagnosis can be difficult. The aim of this study is to improve the assessment of patients with PH using novel magnetic resonance techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2012

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

4.8 years

First QC Date

June 8, 2012

Last Update Submit

September 28, 2015

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • pulmonary artery diameter (mm)

    Three-dimensional MRI imaging will be used to acquire cardiac dimensions and anatomical ventilation distribution as well as regional partial pressures of oxygen in the lungs.

    up to 3 months

Study Arms (1)

3-Helium inhalation gas

EXPERIMENTAL

This is a pilot study. The aim is to recruit 20 patients who will all receive the product under investigation.

Other: 3-Helium gas

Interventions

3-Helium gasOTHER

3-Helium gas for MRI contrast

3-Helium inhalation gas

Eligibility Criteria

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

You may qualify if:

  • All cases referred to the clinic for assessment for possible pulmonary hypertension.

You may not qualify if:

  • patients with a cardiac pacemaker or retained temporary pacing wire
  • patients with aneurysm clip
  • non MRI compatible heart valve prosthesis
  • intra orbital metalic foreign body
  • pregnancy
  • metal prosthesis/spinal rods
  • retained shrapnel
  • cochlear implants/bladder stimulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Pulmonary Vascular Disease Unit, Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10, United Kingdom

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Charlie Elliot, MBChB MRCP

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2012

First Posted

January 3, 2014

Study Start

November 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 30, 2015

Record last verified: 2015-09

Locations

GB(1)