Prognosis of Isolated Left Ventricular Non-compaction in Adults

NCT02885363 | Completed

• 2 other identifiers: 2011-202011-A00987-34
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Non Compaction

Outcome Measures

Primary Outcomes (3)

• Occurrence of death of cardiac origin

  Up to 2 years

• Occurrence of a cardiac transplantation

  Up to 2 years

• Occurrence of hospitalization due to cardiac event

  Up to 2 years

Study Arms (2)

Patients with newly diagnosed Left Ventricular Non Compaction

EXPERIMENTAL

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

Patients with Idiopathic Dilated Cardiomyopathy

ACTIVE COMPARATOR

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

Interventions

Clinical examination OTHER

Patients with Idiopathic Dilated Cardiomyopathy; Patients with newly diagnosed Left Ventricular Non Compaction

Blood sample OTHER

Patients with Idiopathic Dilated Cardiomyopathy; Patients with newly diagnosed Left Ventricular Non Compaction

Echocardiography PROCEDURE

Patients with Idiopathic Dilated Cardiomyopathy; Patients with newly diagnosed Left Ventricular Non Compaction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone

Marseille, 13005, France

Location

MeSH Terms

Interventions

Restraint, Physical; Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Catherine GEINDRE

  Assistance Publique Hôpitaux de Marseille

  STUDY DIRECTOR

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: August 17, 2016
• First Posted: August 31, 2016
• Study Start: December 21, 2011
• Primary Completion: October 23, 2015
• Study Completion: April 12, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

FR (1)