New MRI scan could replace invasive heart test for lung pressure patients
NCT ID NCT03928002
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether a special MRI scan (4D Flow) can accurately measure blood flow to the lungs in people with both congenital heart disease and pulmonary hypertension. The standard test for this is a heart catheterization, which is invasive and uncomfortable. The study involved 50 patients aged 7 and older. Researchers compared the MRI results to the catheterization results to see if the MRI could be a reliable, non-invasive alternative for monitoring these patients.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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50 people
The number who actually took part.
- Started
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May 2018
- Finished
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Nov 2021
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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7 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient ≥ 7 years old * Patient affiliated to a social security system * Giving their informed consent for the study (adults, parents of minors) * Patients with PAH associated with congenital heart disease requiring cardiac catheterization and 2D MRI for the diagnosis or follow-up of PAH associated with congenital heart disease Exclusion Criteria: * \> Patient \< 7 years old * Pregnant woman * Contraindications to MRI (claustrophobia, intraocular metal foreign bodies, pacemaker, neurostimulator, cochlear implants, old heart valves) * Contraindication to gadolinium injection (allergy, renal failure with DFG \< 30 ml/min/1.73m²) * Hemodynamically unstable patients * Refusal to participate
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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centre chirurgical Marie Lannelongue
Le Plessis-Robinson, 92350, France
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Other studies related to the condition(s) this trial covers.
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