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CompletedNCT04439942CMHFLUXUpdated Aug 23, 2023

4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy

An observational study in Hypertrophic Cardiomyopathy, Obstruction and Echocardiography, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-23.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study summary

Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.

The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.

02

Conditions studied

  • Hypertrophic Cardiomyopathy
  • Obstruction
  • Echocardiography

Keywords

  • Hypertrophic Cardiomyopathy
  • 4D-flow magnetic resonance imaging
  • Obstruction
  • maximal gradient
  • echocardiography
03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's enrollment of 26 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with Hypertrophic cardiomyopathy will undergo Doppler-echocardiography followed promptly (within the same hour) by a complete cardiac MRI with the addition of a 4D Flow sequence (does not require the injection of a contrast agent and does not prolong the duration of the examination).

Inclusion criteria

  • Age ≥ 18 years old
  • Presence of a Hypertrophic cardiomyopathy (HCM)
  • Affiliation to a social security program
  • Ability of the subject to understand and express opposition

Exclusion criteria

Exclusion Criteria:

  • Major obesity (> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
  • Age \< 18,
  • Person under guardianship or curators,
  • Pregnant woman,
  • Allergy to gadolinium chelates,
  • Claustrophobia,
  • Any contraindications to MRI
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No

Interventions

  • Othercardiac magnetic resonance imaging (MRI)

    Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.

06

What researchers measure

Primary outcomes

  1. Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by echocardiography.

    Correlation coefficient assessment between the maximum gradient obtained by 4D flow

    Time frame: day 1

Secondary outcomes

  1. Value of Correlation coefficient between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast

    Correlation coefficient assessment between the maximum gradient obtained by 4D flow MRI and the maximum gradient measured by phase-contrast

    Time frame: day 1

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04439942
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jun 19, 2020
Start date
Jun 17, 2020
Primary completion
Jun 1, 2023
Completion
Jun 1, 2023
Last update
Aug 23, 2023

Study contacts

Cédric Renard, MD
principal investigator · CHU Amiens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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