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

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ClinicalTrials.gov Identifier: NCT03928002
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

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.


Condition or disease Intervention/treatment Phase
Congenital Heart Disease Pulmonary Arterial Hypertension Other: 4D Flow magnetic resonance imagery Procedure: Cardiac catheterization Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: MRI 4DFlow Cardiac cathetherization
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 4DFlow Magnetic Resonance Imaging in Patients With Pulmonary Hypertension Associated With Congenital Heart Disease
Actual Study Start Date : May 30, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : October 1, 2020


Arm Intervention/treatment
Experimental: 4DFlow magnetic resonance imagery
2D MRI, essential for diagnosis and monitoring of PAH, with an additional 8 minutes for 4D flow
Other: 4D Flow magnetic resonance imagery
acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information

Active Comparator: Cardiac catheterization
cardiac catheterization procedure using the Fick method; gold standard
Procedure: Cardiac catheterization
pulmonary vascular resistance calculation ;




Primary Outcome Measures :
  1. Compare the evaluation of pulmonary cardiac output (Qp) by 4D Flow MRI and cardiac catheterization using the Fick method. [ Time Frame: one year ]
    Define the value of 4D flow imaging in relation to cardiac catheterization in the evaluation of Qp (Cardiac Output Pulmonary)


Secondary Outcome Measures :
  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 [ Time Frame: one year ]
    Qp/Qs by 4D Flow and cardiac catheterization Qp per 4D Flow and 2D MRI Qp/Qs by 4D Flow and 2D MRI



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928002


Contacts
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Contact: HASCOET SEBASTIEN, MD +33140942429 s.hascoet@hml.fr

Locations
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France
centre chirurgical Marie Lannelongue Recruiting
Le Plessis-Robinson, France, 92350
Contact: HASCOET SEBASTIEN, PI    +33140942429    s.hascoet@hml.fr   
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
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Principal Investigator: HASCOET SEBASTIEN, MD Centre Chirurgical Marie Lannelongue

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03928002     History of Changes
Other Study ID Numbers: 2018-A00332-53
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Chirurgical Marie Lannelongue:
Eisenmenger
Pulmonary arterial hypertension
Magnetic resonance imaging
4Dflow imagery
cardiac catheterization

Additional relevant MeSH terms:
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Hypertension
Heart Diseases
Hypertension, Pulmonary
Familial Primary Pulmonary Hypertension
Heart Defects, Congenital
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Cardiovascular Abnormalities
Congenital Abnormalities