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

NCT02352129 | Completed

• 1 other identifier: 2011-A00887-34
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Prognostic value of the increased level of myocardial fibrosis

  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

  two years

Secondary Outcomes (1)

• hemodynamic consequences of the increased level of myocardial fibrosis

  txw years

Study Arms (2)

Cardiomyopathy dilated patient

EXPERIMENTAL

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

Other: CMR using T1 mapping technique

healthy subjects

ACTIVE COMPARATOR

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

Other: CMR using T1 mapping technique

Interventions

CMR using T1 mapping technique OTHER

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

Cardiomyopathy dilated patient; healthy subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 36747201 RESULT

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• alexis JACQUIER, MD

  Assistance Public Hôpitaux de marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: February 2, 2015
• Study Start: December 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 8, 2026

Record last verified: 2022-03

Locations

FR (1)