- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05624242
Assessment of Right Ventricular Function by Cardiac MRI in Patients With Pulmonary Arterial Hypertension (IRMA) (IRMA)
March 30, 2026 updated by: Central Hospital, Nancy, France
Assessment of Right Ventricular Function by Cardiac Magnetic Resonance Imaging in Patients With Pulmonary Arterial Hypertension (IRMA)
Pulmonary hypertension (PH) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmHg, which encompasses many very dissimilar conditions.
Cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation.
Thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension.
This work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Pulmonary hypertension (PH) is a pathophysiological condition defined by an increase in pulmonary arterial pressure above 20mmHg, which encompasses many very dissimilar conditions.
Right ventricular function is the major determinant of survival in these patients.
Currently, right ventricular function is estimated by trans-thoracic echocardiography via the measurement of standardised parameters.
However, cardiac magnetic resonance imaging is now the reference technique for non-invasive quantification of volumes, mass, function of the right ventricle but can also be useful for the consideration of the pulmonary circulation.
Thus, indices of function can be extracted and it plays an increasing role in the prognostic evaluation of the right heart function at diagnosis and at re-evaluation under treatment of pulmonary arterial hypertension.
This work will initially focus on the assessment of right ventricular myocardial work by echocardiography and cardiac magnetic resonance imaging in comparison with invasive haemodynamic data.
Study Type
Observational
Enrollment (Actual)
112
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Grand Est
-
Nancy, Grand Est, France, 54000
- Simon Valentin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
The study population concerns patients with pulmonary arterial hypertension (group 1 or 4) followed up in our centre, at diagnosis and when starting vasodilator treatment.
Description
Inclusion Criteria:
- Patient with pulmonary arterial hypertension (group 1) or chronic thrombo-embolic pulmonary hypertension (group 4)
- Patient with cardiac MRI and right heart catheterisation within 1 month or without drug modification between the two
Exclusion Criteria:
- Patient with features of venous/capillary involvement
- Pulmonary arterial hypertension associated with with congenital heart disease
- Patient's decline to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transplantation-free survival
Time Frame: 12 months
|
time to transplantation OR death
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon Valentin, MD, Université de Lorraine, Département de Pneumologie, CHRU NANCY
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 24, 2023
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
January 1, 2026
Study Registration Dates
First Submitted
November 14, 2022
First Submitted That Met QC Criteria
November 14, 2022
First Posted (Actual)
November 22, 2022
Study Record Updates
Last Update Posted (Actual)
April 3, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022PI113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.