Prognosis of Isolated Left Ventricular Non-compaction in Adults

NCT ID: NCT02885363

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-21
• Study Completion Date: 2023-04-12

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.

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.

Conditions

Left Ventricular Non Compaction

Study Design

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

Study Groups

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

Group Type: EXPERIMENTAL

Clinical examination

Intervention Type: OTHER

Blood sample

Intervention Type: OTHER

Echocardiography

Intervention Type: PROCEDURE

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

Group Type: ACTIVE_COMPARATOR

Clinical examination

Intervention Type: OTHER

Blood sample

Intervention Type: OTHER

Echocardiography

Intervention Type: PROCEDURE

Interventions

Clinical examination

Intervention Type: OTHER

Blood sample

Intervention Type: OTHER

Echocardiography

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone

Marseille, , France

Countries

France

Other Identifiers

2011-A00987-34

Identifier Type: OTHER

Identifier Source: secondary_id

2011-20

Identifier Type: -

Identifier Source: org_study_id