Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion

Pulmonary Hypertension Clinical Trial

Official title:

Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion: Its Role in the Diagnosis of the Severity of Pulmonary Hypertension in Adults and in the Follow-up. Preliminary Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01100008
• Other study ID #: 06 042 02
• Status: Completed
• Phase: N/A
• First received: March 1, 2010
• Last updated: March 11, 2016
• Start date: September 2007
• Est. completion date: June 2014

Study information

• Verified date: March 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Thirty patients will be enrolled and followed for 1 year after their inclusion.

Cardiac MRI will be performed at inclusion and at 3 months and 12 months. At the same periods, echocardiography and right heart catheterization will be performed too.

Morphological and functional parameters will be studied with MRI and correlated to invasive parameters and echocardiography too.

Morphological parameters are: volumes, cardiac cavities areas and ratios and position of the interventricular septum. Functional parameters are: ejection fractions of right and left cavities, flow in pulmonary artery, across mitral and tricuspid valves, temporal measurements in the pulmonary artery and auriculoventricular valves.

The invasive measurements are considered as the gold standard for this study. The classification of the severity is defined according to the parameters from right cardiac catheterization (4 grades with severity increasing between 1 and 4).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults patients with pulmonary hypertension without specific treatment at inclusion

• Etiologies include chronic embolic disease, systemic fibrosis, Gougerot Sjogren, drug induced hypertension, primary hypertension.

• informed consent

• affiliated to medical insurance.

Exclusion Criteria:

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Procedure:
• Magnetic resonance imaging (MRI)
MRI cardiac and pulmonary with gadolinium

Locations

Country	Name	City	State
France	Service de radiologie - Hôpital Rangueil	Toulouse	Midi-Pyrénées

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No