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Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Cardiomyopathy, Dilated

Treatments

Other: CMR using T1 mapping technique

Study type

Interventional

Funder types

Other

Identifiers

NCT02352129
2011-A00887-34

Details and patient eligibility

About

: Fibrosis, in general, is a scarring process, which is characterized by fibroblast accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to distorted organ architecture and function. The contribution of fibrogenesis to impaired cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and induces pathological signaling within cardiomyocytes resulting in progressive cardiac failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and increases the risk of arrhythmias. But today patient treatment and prognosis is based on ejection fraction quantification, QRS duration, and symptoms.

Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared with normal value, is of prognostic value in patient with dilated cardiomyopathies under optimal treatment.

Methods: 330 patients are planned to be included and followed for 2 years

Enrollment

262 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • patient with dilated cardiomyopathy and typical symptoms of cardiac insufficiency at the time of the diagnosis: oedemas of lower limbs, dyspnoea, asthenia.
  • and of a reduction in the fraction of ventricular ejection left (awkward) 45 % measured in echocardiography ( modified Simpson biplane) and associated with a volume télédiastolic volume superior to the normal in echocardiography: > 90ml / m2 ( modified Simpson biplane).

Exclusion criteria

  • Patients to whom the dysfunction VG is secondary or in a secondary overload of pressures in a HTA or a severe valvulopathie is in a coronary infringement(achievement), proved by histories of infarct or gestures(movements) of revascularisation (bypass(decking), stent) and or coronary hurts at least bi tronculaires significant the severity of which can explain the ventriculaire failure.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

262 participants in 2 patient groups

Cardiomyopathy dilated patient
Experimental group
Description:
Cardiomyopathy dilated patients wil be evalueted by CMR using T1 mapping technique to evalueted the level myocardial fibrosis
Treatment:
Other: CMR using T1 mapping technique
healthy subjects
Active Comparator group
Description:
healthy subject wil be evaluated by CMR using T1 mapping technique to know the baseline of myocardial fibrosis in healthy subjects
Treatment:
Other: CMR using T1 mapping technique

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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