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AzTrials

Congenital Heart Disease4DFlowHTAPCCNCT03928002

4DFlow Magnetic Resonance Imaging in Patients With Pulmonary Hypertension Associated With Congenital Heart Disease

A study testing 4D Flow magnetic resonance imagery and Cardiac catheterization in people with Congenital Heart Disease and Pulmonary Arterial Hypertension, run by Centre Chirurgical Marie Lannelongue at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Congenital heart disease is the most common congenital anomaly. The life expectancy of children with congenital heart disease has increased considerably in recent years. Nevertheless, the evolution of these patients is marked by an increased risk of complications. Read more about this study

Who is it for?
Ages 7 years and older
What is being tested?
4D Flow magnetic resonance imagery and Cardiac catheterization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteFrance
Study dates
30 May 2018to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • > 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • centre chirurgical Marie Lannelongue

    Le Plessis-Robinson, 92350

Other trials in France

About this study

Congenital heart disease is the most common congenital anomaly. The life expectancy of children with congenital heart disease has increased considerably in recent years.

Nevertheless, the evolution of these patients is marked by an increased risk of complications. Arrhythmias, heart failure, pulmonary arterial hypertension (PAH) and endocarditis may be promoted by the absence or delay of management in childhood, by residual lesions or post-operative cardiac scars and by the presence of prosthetic materials.

Read more

PAH is a common complication of congenital heart disease, especially in non-operated shunts.

PAH corresponds to an increase in pulmonary vascular resistance and mean pulmonary arterial pressure that becomes greater than 25mmHg at rest, leading to right ventricular failure and ultimately to the patient's death.

Eisenmenger's syndrome corresponds to a non-reversible pulmonary arterial hypertension with a left-right shunt initially left open, then right-left secondary to the increase in pulmonary vascular resistance, leading to cyanosis, polycythemia and multivisceral involvement. It is the most advanced form of PAH with congenital heart disease.

PAH will be suspected during echocardiographic follow-up of any patient with congenital heart disease, on the analysis of the velocity of tricuspid and/or pulmonary regurgitation flow.

Echocardiography allows the monitoring of the VD (right ventricle) function, which is the major prognostic element in PAH. Cardiac catheterization is systematically recommended and remains the gold standard to confirm the diagnosis of PAH, establish its pathophysiology and prognosis but also for the follow-up under medical treatment of these patients in tertiary centres every 6 months. Although this tool is the gold standard, rigorously performed, it remains an invasive examination often poorly experienced by patients.

4D Flow MRI is a promising imaging that allows the acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information in a single step with 2D (only 8 minutes extra), in free breathing and totally autonomous mode. Thus, at the same time as the realization of a 2D MRI, essential for the diagnosis and follow-up of PAH, with an additional 8 minutes for 4D flow, the investigators could have additional fundamental information on pulmonary cardiac output but also prognostic markers of right ventricular dysfunction turning dramatic in pulmonary vascular disease.

Read the detailed description

Cardiac catheterization is systematically recommended and remains the gold standard to confirm the diagnosis of PAH, establish its pathophysiology and prognosis but also for the follow-up under medical treatment of these patients in tertiary centres every 6 months. Some centres repeat invasive hemodynamic assessment in the event of clinical aggravation before considering a change in drug management or overall management. This is the reference examination for the calculation of PVRs, an extremely rigorous methodology is required in patients with intracardiac shunt: the Fick principle must then be applied to calculate Qp. Usually, it is calculated by thermodilution but is no longer applicable in the case of intracardiac shunt, as is significant valvulopathy or massive tricuspid leakage. Qp is equal to the oxygen consumption (MVO2) divided by the difference in oxygen content (CaO2) between the pulmonary artery and the pulmonary veins (VP). Qp= MVO2/ (CaO2VP- CaO2 AP). They must be carried out with a rigorous methodology adapted on a case-by-case basis according to the anatomy and hemodynamics of the heart disease and a precise knowledge of the limits of the technique, in expert centres in PAH and congenital heart disease and must not be seen as without consequences for the patient . Although this tool is the gold standard, rigorously carried out in our reference centre, with rare accidents or potential risks, it remains an invasive examination often poorly experienced by patients .

Magnetic resonance imaging (MRI) has emerged in recent years as the reference technique for non-invasive morphological and functional evaluation of the right ventricle. It also seems relevant for the study of pulmonary arterial hemodynamics while providing prognostic values for PAH. Its regular implementation is indicated in the 2015 ESC guidelines for the diagnosis and follow-up of patients, with more particularly an injection of gadolinium for the search for myocardial fibrosis, a marker of right ventricular remodelling. Also considered are: decrease in right ventricular ejection fraction, paradoxical septal kinetics, decrease in left ventricular dimensions, compliance of the pulmonary artery (mL/mmHg) and mean flow velocity (cm/s). Carrying out this examination using conventional techniques (2D MRI) has some limitations. Extrinsic, linked to operators and observers. The quality of the examinations here depends on the quality of the acquisitions made by the radiology manipulators (sequences / section plans) as well as an adapted analysis of these cardiopathies. All of this involves a high degree of technical expertise on the part of paramedical staff, as well as expertise in congenital heart disease and cardiac imaging for medical staff. Finally, this examination has intrinsic limitations, since it does not allow the characteristics of intracardiac or vascular flows (turbulence, direction, vortex) to be explored. All this implies an examination time of about 30 minutes 4D Flow MRI is a promising imaging that allows the acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information in a single step with 2D (only 8 minutes extra), in free breathing and totally autonomous mode. It is a sequence allowing a quasi-isotopic, retrospective analysis, providing information on blood flow in the 3 planes of the space, during the cardiac cycle. It is not influenced by the quality of the medical teams and, above all, it allows an unlimited post-processing capacity. This innovative imaging method is therefore particularly suitable for the study of cardiac output such as Qp. The right ventricular volume is difficult to analyze due to the complexity of its geometry, automatic segmentation is still under development, this element seems to be a promising hemodynamic parameter since it is quantitatively calculated and seems to be correlated with the systolic function of the left ventricle and inaccessible to conventional techniques due to the particular geometry of the right ventricle. Previous studies have demonstrated the possibility of qualitative analysis of intraventricular blood flows by studying retrograde flows, vortices and their kinetic energy, which are involved in diastolic dysfunction of the right ventricle .Studies have shown that these structures can be altered in PAH dog models but also in repaired Fallot tetralogy series and Fontan type circulations .

Thus, at the same time as the realization of a 2D MRI, essential for the diagnosis and follow-up of PAH, with an additional 8 minutes for 4D flow, the investigators could have additional fundamental information on pulmonary cardiac output but also prognostic markers of right ventricular dysfunction turning dramatic in pulmonary vascular disease.

Our objective is to evaluate the contribution of 4D MRI flow imaging to the measurement of pulmonary cardiac output compared to the gold standard which is cardiac catheterization using the Fick method. But also, to compare 2D and 4D MRI flow for the evaluation of volumes, function and right ventricular remodeling, as well as the quantification of pulmonary, tricuspid and systemic flows.

Being tested
4D Flow magnetic resonance imagery, Cardiac catheterization
Keywords
Eisenmenger, Pulmonary arterial hypertension, Magnetic resonance imaging, 4Dflow imagery, cardiac catheterization
Medical subject headings
Heart Defects, Congenital, Pulmonary Arterial Hypertension, Eisenmenger Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4D Flow magnetic resonance imageryOther

    acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information

  • Cardiac catheterizationProcedure or surgery

    pulmonary vascular resistance calculation ;

Study groups in NCT03928002
Study groupRoleWhat they receive
4DFlow magnetic resonance imageryExperimental2D MRI, essential for diagnosis and monitoring of PAH, with an additional 8 minutes for 4D flow
Receives: Other: 4D Flow magnetic resonance imagery
Cardiac catheterizationActive comparatorcardiac catheterization procedure using the Fick method; gold standard
Receives: Procedure: Cardiac catheterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the evaluation of pulmonary cardiac output (Qp) by 4D Flow MRI and cardiac catheterization using the Fick method.

    Define the value of 4D flow imaging in relation to cardiac catheterization in the evaluation of Qp (Cardiac Output Pulmonary)

    Measured: one year

Secondary outcomes (1)
  1. ratio of Qp/Qs flow rates by 4D Flow and cardiac catheterization Qp by 4D Flow and 2D MRI volumes and right ventricular systolic function by 4D Flow and 2D MRI

    Qp/Qs by 4D Flow and cardiac catheterization Qp per 4D Flow and 2D MRI Qp/Qs by 4D Flow and 2D MRI

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start30 May 2018
  3. Primary completion30 Nov 2021
  4. Study completion30 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
MRI 4DFlow Cardiac cathetherization
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03928002
Sponsor's protocol ID
2018-A00332-53
Acronym
4DFlowHTAPCC
Status last verified
Apr 2026
First submitted
23 Apr 2019
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing 4D Flow magnetic resonance imagery and Cardiac catheterization in people with Congenital Heart Disease and Pulmonary Arterial Hypertension, run by Centre Chirurgical Marie Lannelongue at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the evaluation of pulmonary cardiac output (Qp) by 4D Flow MRI and cardiac catheterization using the Fick method. (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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