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4D-flow Cardiac MRI to Assess Pulmonary Arterial Pressure in Pulmonary Hypertension

4D Flow Cardiac MRI Velocity Mapping in Patients With Pulmonary Hypertension: Estimation of Pulmonary Arterial Pressure and Comparison With Right Heart Catheterization and Doppler Echocardiography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05103189
Acronym
HTPFLUW
Enrollment
28
Registered
2021-11-02
Start date
2021-10-21
Completion date
2023-07-01
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Echocardiography, Magnetic Resonance Imaging, Pulmonary Arterial Pressure, Pulmonary Hypertension, Right Heart Catheterization

Keywords

Pulmonary Hypertension, 4D-flow magnetic resonance imaging, mean pulmonary arterial pressure, right heart catheterization, echocardiography

Brief summary

Due to radiation exposure and low but real risk of morbidity and mortality associated with right heart catheterization, non-invasive procedures to estimate mPAP are desired for the diagnosis of PH or to monitor treatment effectiveness. Echocardiography is used as a screening tool to estimate systolic pulmonary arterial pressure (sPAP), but due various limitations, this technique is not considered to be sufficiently accurate for the diagnosis of PH. The aim of 4D flow MRI is to evaluate the complete time-varying tridirectional velocity field in a volume of interest. It enables flow and velocity measurements in a vascular region of interest and visualization of vector plots of blood flow velocity fields. Previous studies have shown on the one hand, correlations between mPAP and hemodynamic parameters obtained by phase contrast MRI and, on the other hand, appearance of a vortical blood flow in the pulmonary artery in PH. More studies are required to confirm 4D MRI as a valuable tool for mPAP estimation in PH. Following screening echocardiography, all patients will undergo right heart catheterization for PH assessment. Then, all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography. The data from each examination will be blindly interpreted from the results of the other one. No follow-up will be required for the study.

Interventions

OTHER4D-flow sequence

all patients will be referred for a complete cardiac MRI exam with the addition of a 4D Flow sequence (does not require supplementary injection of a contrast agent and does not extend the duration of the examination) followed promptly (within the same hour) by a Doppler-echocardiography.

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years old, * Patient referred for cardiac MRI who previously underwent right heart catheterization for pulmonary hypertension assessment, * Affiliation to a social security program, * Ability of the subject to understand and express opposition

Exclusion criteria

* Age \<18 years old, * Major obesity (\> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70 cm, * Person under guardianship or curators, * Pregnant woman, * Allergy to gadolinium chelates, * Claustrophobia, * Any contraindications to MRI

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficient between the values of mPAP (mmHg) and right heart catheterization rate.30 minutesmPAP is obtained by 4D flow MRI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026