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

NCT ID: NCT02352129

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2017-06-30

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

Conditions

Cardiomyopathy, Dilated

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cardiomyopathy dilated patient

Cardiomyopathy dilated patients wil be evalueted by CMR using T1 mapping technique to evalueted the level myocardial fibrosis

Group Type: EXPERIMENTAL

CMR using T1 mapping technique

Intervention Type: OTHER

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

healthy subjects

healthy subject wil be evaluated by CMR using T1 mapping technique to know the baseline of myocardial fibrosis in healthy subjects

Group Type: ACTIVE_COMPARATOR

CMR using T1 mapping technique

Intervention Type: OTHER

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

Interventions

CMR using T1 mapping technique

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

alexis JACQUIER, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Public Hôpitaux de marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

References

Cadour F, Quemeneur M, Biere L, Donal E, Bentatou Z, Eicher JC, Roubille F, Lalande A, Giorgi R, Rapacchi S, Cortaredona S, Tradi F, Bartoli A, Willoteaux S, Delahaye F, Biene SM, Mangin L, Ferrier N, Dacher JN, Bauer F, Leurent G, Lentz PA, Kovacsik H, Croisille P, Thuny F, Bernard M, Guye M, Furber A, Habib G, Jacquier A. Prognostic value of cardiovascular magnetic resonance T1 mapping and extracellular volume fraction in nonischemic dilated cardiomyopathy. J Cardiovasc Magn Reson. 2023 Feb 6;25(1):7. doi: 10.1186/s12968-023-00919-y.

Reference Type: DERIVED

PMID: 36747201 (View on PubMed)

Other Identifiers

2011-A00887-34

Identifier Type: -

Identifier Source: org_study_id