NCT01100008

Brief Summary

Pulmonary hypertension is a rare severe disease leading to cardiac insufficiency. Treatment depends on the severity of the disease. This study evaluates cardiac MRI for the assessment of pulmonary hypertension severity and identification of parameters useful for the follow-up in order to adapt the medical treatment to status of the patient. Evaluate if cardiac MRI can obviate right cardiac catheterization in the follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

September 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 14, 2016

Status Verified

March 1, 2016

Enrollment Period

6 years

First QC Date

March 1, 2010

Last Update Submit

March 11, 2016

Conditions

Keywords

Pulmonary arterial hypertensioncardiac MRI (magnetic resonance imaging)severityprognosis

Outcome Measures

Primary Outcomes (1)

  • Nuclear magnetic resonance imaging

    Correlation of cardiac results from the first MRI (Magnetic Resonance Imaging) to invasive measurements from the first or initial right heart catheterization and to echocardiography to know if cardiac MRI is able to predict severity of the disease

    Inclusion ; 3rd month ; 12th month

Study Arms (1)

Magnetic resonance imaging

EXPERIMENTAL
Procedure: Magnetic resonance imaging (MRI)

Interventions

MRI cardiac and pulmonary with gadolinium

Magnetic resonance imaging

Eligibility Criteria

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

You may qualify if:

  • Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.
  • informed consent
  • affiliated to medical insurance.

You may not qualify if:

  • Left cardiac disease responsible for pulmonary hypertension, congenital cardiopathies
  • Pulmonary functional tests with important impairment (decrease in TPCmore than 30%, decrease In VEMS more than 30%
  • Child
  • pregnancy
  • contraindications to MRI
  • without informed consent
  • without insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de radiologie - Hôpital Rangueil

Toulouse, Midi-Pyrénées, 31000, France

Location

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Arterial Hypertension

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Valérie Chabbert, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

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

March 1, 2010

First Posted

April 8, 2010

Study Start

September 1, 2007

Primary Completion

September 1, 2013

Study Completion

June 1, 2014

Last Updated

March 14, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations