Prognosis of Isolated Left Ventricular Non-compaction in Adults

Left Ventricular Non Compaction Clinical Trial

— NCVG  

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
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 12, 2023
• Est. primary completion date: October 23, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Left Ventricular Non Compaction

Intervention

Other:
• Clinical examination

• Blood sample

Procedure:
• Echocardiography

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of death of cardiac origin		Up to 2 years
Primary	Occurrence of a cardiac transplantation		Up to 2 years
Primary	Occurrence of hospitalization due to cardiac event		Up to 2 years