Left Ventricular Non CompactionNCVGNCT02885363
Prognosis of Isolated Left Ventricular Non-compaction in Adults
A study testing Clinical examination, Blood sample and Echocardiography in people with Left Ventricular Non Compaction, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Non Compaction
- What is being tested?
- Clinical examination, Blood sample and Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- 21 Dec 2011to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille, Hôpital de la Timone
Marseille, 13005
About this study
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.
Read the 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:
- - there is no evidence that prognosis is different from other forms of cardiomyopathies.
- - 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
- Being tested
- Clinical examination, Blood sample, Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
Blood sampleOther
EchocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Clinical examination; Other: Blood sample; Procedure: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of death of cardiac origin
Measured: Up to 2 years
Occurrence of a cardiac transplantation
Measured: Up to 2 years
Occurrence of hospitalization due to cardiac event
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start21 Dec 2011
- Primary completion23 Oct 2015
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Non CompactionStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine GEINDRE, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885363
- Sponsor's protocol ID
- 2011-20
- Other IDs
- 2011-A00987-34
- Acronym
- NCVG
- Status last verified
- Apr 2023
- First submitted
- 17 Aug 2016
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Isolated Left Ventricular Non-compaction in Adults
- ClinicalTrials.gov ID
- NCT02885363
- Acronym / sponsor ID
- NCVG / 2011-20
- Conditions
- Left Ventricular Non Compaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 21 Dec 2011 (actual)
- Primary completion
- 23 Oct 2015 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- - there is no evidence that prognosis is different from other forms of cardiomyopathies.
- - 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with newly diagnosed Left Ventricular Non Compaction | Experimental | Other: Clinical examination, Other: Blood sample, Procedure: EchocardiographyPatient newly diagnosed with Left Ventricular Non Compaction (diagnose < 6 months), confirmed by echocardiography associated or not with MRI, after centralized review |
| Patients with Idiopathic Dilated Cardiomyopathy | Active comparator | Other: Clinical examination, Other: Blood sample, Procedure: EchocardiographyPatient newly diagnosed with Idiopathic Dilated Cardiomyopathy (diagnose < 6 months), confirmed by echocardiography associated or not with MRI, after centralized review |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Patients with Idiopathic Dilated Cardiomyopathy, Patients with newly diagnosed Left Ventricular Non Compaction |
Primary outcome
Occurrence of death of cardiac origin
Time frame: Up to 2 years
Occurrence of a cardiac transplantation
Time frame: Up to 2 years
Occurrence of hospitalization due to cardiac event
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Left Ventricular Non Compaction
RecruitingObservational study
Pediatric Cardiomyopathy Mutation Analysis
Cardiomyopathies, Dilated Cardiomyopathy
RecruitingObservational study
Predictors of Risk in Left Ventricular Non-Compaction
Left Ventricular Noncompaction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine GEINDRE study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination, Blood sample and Echocardiography in people with Left Ventricular Non Compaction, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of death of cardiac origin (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.