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Prognosis of Isolated Left Ventricular Non-compaction in Adults (NCVG)

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ClinicalTrials.gov Identifier: NCT02885363
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:
The main objective of this study is to clarify prospectively prognosis of patients newly diagnosed as carriers of a LVNC (incident cases) (i.e. without the occurrence of a survival of the following events: death, heart transplantation or hospitalization for cardiovascular complications). In a second time, prognosis factors will be identify in these patients with LVNC.

Condition or disease Intervention/treatment Phase
Left Ventricular Non Compaction Other: Clinical examination Other: Blood sample Procedure: Echocardiography Not Applicable

Detailed Description:

Isolated Left Ventricular Non Compaction (LVNC) is a rare cause of cardiomyopathy supposed to result from the cessation of normal embryogenesis infarction, and characterized by persistent ventricular trabeculations prominent.

This is frequently a familial disease, but for which genetic characterization is still incomplete, and then requires the identification of new genes is desirable.

The prognosis of LVNC is uncertain, with a mortality rate reported in the literature ranging from 2 to 38%. Some series conclude that LVNC is a very severe heart disease, responsible for a high mortality, other that LVNC is frequently associated with a favorable prognosis. These series are however limited by the short duration of follow-up and the small number of patients included.

Between 2004 and 2006, a French registry LVNC, included 105 cases. It was found out that the LVNC was associated with a high rate of complications such as outbreaks of severe heart failure, need for heart transplantation, severe rhythm disorders, and embolic events. The prognosis of LVNC in France appears as pejorative:

  1. - there is no evidence that prognosis is different from other forms of cardiomyopathies.
  2. - the results of this register can be skewed by the inclusion of incident and prevalent cases (statistical survival bias).

Thus, a longer-term monitoring and the identification of relevant prognostic markers are imperative to better understand this rare disease and to improve the therapeutic management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : December 2011
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : April 2018


Arm Intervention/treatment
Experimental: Patients with newly diagnosed Left Ventricular Non Compaction
Patient newly diagnosed with Left Ventricular Non Compaction (diagnose < 6 months), confirmed by echocardiography associated or not with MRI, after centralized review
Other: Clinical examination
Other: Blood sample
Procedure: Echocardiography
Active Comparator: Patients with Idiopathic Dilated Cardiomyopathy
Patient newly diagnosed with Idiopathic Dilated Cardiomyopathy (diagnose < 6 months), confirmed by echocardiography associated or not with MRI, after centralized review
Other: Clinical examination
Other: Blood sample
Procedure: Echocardiography



Primary Outcome Measures :
  1. Occurrence of death of cardiac origin [ Time Frame: Up to 2 years ]
  2. Occurrence of a cardiac transplantation [ Time Frame: Up to 2 years ]
  3. Occurrence of hospitalization due to cardiac event [ Time Frame: Up to 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged over 18 years
  • Presenting with Left Ventricular Non Compaction (LVNC, Group 1) or Idiopathic Dilated Cardiomyopathy (DCM, Group 2)
  • At distance of an acute heart failure thrust (> 1 month)
  • Newly diagnosed (less than 6 months)
  • Diagnosis confirmed by echocardiography associated or not with a Magnetic Resonance Imaging (MRI) confirmed after central review
  • Having signed informed consent form

Exclusion Criteria:

  • Age <18 years
  • Patients who were diagnosed more than 6 months ago (prevalent cases)
  • Presence of an associated cardiac disease, including valvular, ischemic, or congenital disease
  • Refusal to sign the informed consent form

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885363


Contacts
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Contact: Gilbert HABIB, Pr 04 91 38 75 87 ext +33 gilbert.habib@free.fr
Contact: Nathalie CHARVIN 04 91 38 17 05 ext +33 nathalie.charvin@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone Recruiting
Marseille, France, 13005
Contact: Gilbert HABIB    04 91 38 75 87    gilbert.habib@free.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Catherine GEINDRE Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02885363    
Other Study ID Numbers: 2011-20
2011-A00987-34 ( Other Identifier: ANSM )
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided