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Clinical Trials/NCT02352129
NCT02352129
Completed
Not Applicable

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

Assistance Publique Hopitaux De Marseille1 site in 1 country262 target enrollmentDecember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy, Dilated
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
262
Locations
1
Primary Endpoint
Prognostic value of the increased level of myocardial fibrosis
Status
Completed
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 2011
End Date
June 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • hemodynamic consequences of the increased level of myocardial fibrosis(txw years)

Study Sites (1)

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