Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02885363 |
Other study ID # |
2011-20 |
Secondary ID |
2011-A00987-34 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
December 21, 2011 |
Est. completion date |
April 12, 2023 |
Study information
Verified date |
April 2023 |
Source |
Assistance Publique Hopitaux De Marseille |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.