Clinical trial NCT01100008: Cardiac Magnetic Resonance Imaging and Pulmonary Perfusion
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Pulmonary arterial hypertension
cardiac MRI (magnetic resonance imaging)
severity
prognosis
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Nuclear magnetic resonance imaging
timeFrame: Inclusion ; 3rd month ; 12th month
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Service de radiologie - Hôpital Rangueil
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: Valérie Chabbert, MD
role: PRINCIPAL_INVESTIGATOR
References: