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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

: 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


Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome: Prognostic value of the increased level of myocardial fibrosis [ Time Frame: two years ]

The long-term forecast of the patients affected by CMD will be estimated by the survival without event. The events considered in this study are included in an associating combined criterion:

  • Death(Deaths), whatever is its cause.
  • The heart transplant
  • Hospitalization for cardiac cause, including acute(sharp) cardiac insufficiency, disorder(confusion) of the rhythm, required by rehabilitation of the treatment(processing), the thrombus ventriculaire left, cerebrovascular accident.
  • Palpitation ventriculaire steady (ventriculaire extrasystole > 120 pulsation for minutes more than 30 on Holter of 24 hours(12 pm)).
  • Palpitation ventriculaire not steady


Original Primary Outcome: Same as current

Current Secondary Outcome: hemodynamic consequences of the increased level of myocardial fibrosis [ Time Frame: txw years ]

The quantity of interstitial fibrosis at the time of the diagnosis will be correlated to the indicators of the reshaping left ventriculaire measured in echocardiography: decrease of more than 10 % of the fraction of ejection over 2 years or increase of the volume télédiastolique furthermore of 20ml / the year.


Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: January 21, 2015
Date Started: December 2011
Date Completion: June 2017
Last Updated: July 26, 2016
Last Verified: July 2016