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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02747485 |
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Date of registration:
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19/04/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases ( The DIFFUsE Study)
DIFFUsE |
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Scientific title:
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Impact of Diffuse Myocardial Fibrosis on the Ventricular Function in Regurgitant Left-Sided Valve Heart Diseases " The DIFFUsE Study " |
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Date of first enrolment:
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May 2016 |
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Target sample size:
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316 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02747485 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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THUNY FRANCK |
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Address:
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Telephone:
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Email:
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franck.thuny@ap-hm.fr |
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Affiliation:
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Name:
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Catherine GEINDRE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique Hopitaux De Marseille |
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Name:
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THUNY franck, PU PH |
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Address:
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Telephone:
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Email:
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franck.thuny@ap-hm.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All consecutive patients referred for organic MR and/or AR at least moderate to severe
according to the ESC guidelines criteria4 will be eligible. The moderate to severe
criteria will defined by echocardiography as followed:
- MR: an effective regurgitant orifice area (EOA) >30mm2 and/or a regurgitant volume
(RV) >45mL
- AR: an EOA >20mm2 and/or a RV >45mL
Exclusion Criteria:
- Age < 18 years
- Pregnancy
- Impossibility to maintain a decubitus position
- Arrhythmia that do not allow an ECG synchronization during MRI
- Hemodynamic instability
- Indication of urgent surgery
- Known coronary artery disease
- Severe arterial hypertension
- Cardiomyopathy
- Claustrophobia
- Gadolinium intolerance
- Implantable medical devices that do allow to perform MRI
- Severe renal insufficiency with clearance <35 mL/min
- Vulnerable patients
- Acute infective endocarditis
- Aortic dissection
- Moderate or severe mitral stenosis (mitral area <1.5cm2/m2)
- Moderate or severe aortic stenosis (aortic area <0.8cm2/m2, or Vmax>3m/s, or mean
gradient>30mmHg)
- Previous cardiac surgery
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Valve Heart Diseases
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Intervention(s)
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Genetic: blood samples
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Biological: blood samples
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Procedure: myocardial biopsy
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Device: Cardiac MRI
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Primary Outcome(s)
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the rate of diffuse myocardial fibrosis
[Time Frame: 6 months]
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Secondary Outcome(s)
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correlation between ECV and the myocardial deformation quantified by speckle tracking echocardiography (2D Strain)
[Time Frame: 42 months]
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Correlations between ECV and the global longitudinal strain and the serum level of Galectin-3 and ST2
[Time Frame: 42 months]
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correlations between ECV and the severity of the regurgitation
[Time Frame: 42 months]
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Correlations between ECV changes and genetic factors
[Time Frame: 42 months]
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Secondary ID(s)
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2015-A00587-42
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2016-11
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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