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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02352129
Enrollment
262
Registered
2015-02-02
Start date
2011-12-01
Completion date
2017-06-01
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiomyopathy, Dilated

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

Interventions

OTHERCMR using T1 mapping technique

the level of myocardial fibrosis for patient suffering of cardiomyopathy dilated will be quantified using CMR T1 mapping technique

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prognostic value of the increased level of myocardial fibrosistwo yearsThe 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

MeasureTime frameDescription
hemodynamic consequences of the increased level of myocardial fibrosistxw yearsThe 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.

Countries

France

Contacts

PRINCIPAL_INVESTIGATORalexis JACQUIER, MD

Assistance Public Hôpitaux de marseille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026