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

NCT03928002 | Completed

• 1 other identifier: 2018-A00332-53
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Congenital Heart Disease; Pulmonary Arterial Hypertension

Keywords

Eisenmenger; Pulmonary arterial hypertension; Magnetic resonance imaging; 4Dflow imagery; cardiac catheterization

Outcome Measures

Primary Outcomes (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)

  one year

Secondary Outcomes (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

  one year

Study Arms (2)

4DFlow magnetic resonance imagery

EXPERIMENTAL

2D MRI, essential for diagnosis and monitoring of PAH, with an additional 8 minutes for 4D flow

Other: 4D Flow magnetic resonance imagery

Cardiac catheterization

ACTIVE COMPARATOR

cardiac catheterization procedure using the Fick method; gold standard

Procedure: Cardiac catheterization

Interventions

4D Flow magnetic resonance imagery OTHER

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

4DFlow magnetic resonance imagery

Cardiac catheterization PROCEDURE

pulmonary vascular resistance calculation ;

Cardiac catheterization

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Centre Chirurgical Marie Lannelongue: lead

Study Sites (1)

centre chirurgical Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Pulmonary Arterial Hypertension; Eisenmenger Complex

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Catheterization; Therapeutics; Investigative Techniques

Study Officials

• HASCOET SEBASTIEN, MD

  Centre Chirurgical Marie Lannelongue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: MRI 4DFlow Cardiac cathetherization

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 25, 2019
• Study Start: May 30, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

FR (1)