Left Ventricular Non-compaction CardiomyopathyNCT01481298
Value of Cardiac Magnetic Resonance (CMR) Derived Parameters for Diagnosing Left Ventricular Non-compaction Cardiomyopathy
An observational study of Left Ventricular Non-compaction Cardiomyopathy and Left Ventricular Failure, run by University of Leipzig at 1 site in Germany.
Trial summary
Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. Read more about this study
- Who is it for?
- Ages 14 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Left Ventricular Non-compaction Cardiomyopathy, Left Ventricular Failure, Left Ventricular Hypertrophy
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2004to Oct 2008
- Phase
- Observational
- 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 14 to 64 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Twelve patients (3 male, 27%) with proven LVNC, two with familial LVNC, were included into the study. The patients initially presented with symptoms of heart failure and were referred to the department of cardiology for further evaluation. All patients underwent echocardiography performed by experienced specialists and fulfilled the LVNC criteria of Jenni. CMR imaging was performed within 3 days after echocardiography. Exclusion criteria were co-existing cardiac anomalies and usual CMR contraindications such as implanted defibrillators/pacemakers. The investigators furthermore included 10 consecutive patients (4 male, 36%) with HCM and 11 consecutive patients (3 male, 27%) with DCM. The diagnosis of HCM and DCM was established according to current guidelines Patient parameters were compared to a control group of 25 healthy age matched volunteers (12 male, 48%) without history of cardiovascular disease and without clinical symptoms.
Who may be able to join
- left ventricular non-compaction cardiomyopathy
- dilatative cardiomyopathy
- hypertrophic cardiomyopathy or healty controls
Who cannot join
- contraindications for magnetic resonance imaging like pacemakers or other metallic implants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of Different Myocardial Parameters to Differentiate Left Ventricular Noncompaction Cardiomyopathy From Other Cardiomyopathies and Healthy Controls by Cardiac Magnetic Resonance
Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. Although most authors assume a developmental arrest in embryogenesis as the underlying pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have been identified to be linked with LVNC and an autosomal dominant inheritance pattern is frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography applying the criteria established by Jenni and coauthors However, qualitative parameters to differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may fail due to highly variable LV trabeculation. Therefore, absolute quantification should be performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality to characterize patients with LVNC as it provides both a high spatial resolution and a good contrast between trabeculation and blood pool Jacquier et al. recently described a value of trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive and specific for LVNC However, in their approach, a substantial degree of the LV cavity was included into calculated trabecular LV mass and led to systemic overestimation of the latter. Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed enhancement (DE) CMR was not evaluated.
The aim of the retrospective study was to establish revised and extended CMR criteria to distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment of trabeculated mass by excluding intertrabecular blood pool.
- Conditions
- Left Ventricular Non-compaction Cardiomyopathy, Left Ventricular Failure, Left Ventricular Hypertrophy
- Medical subject headings
- Heart Failure, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LVNC | 12 patients with left ventricular non-compaction cardiomyopathy | |
| HCM | 10 patients with hypertrophic cardiomyopathy | |
| DCM | 11 patients with dilatative cardiomyopathy | |
| controls | 24 healthy controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startDec 2004
- Primary completionJul 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular Non-compaction CardiomyopathyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Grothoff, M.D., University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481298
- Sponsor's protocol ID
- LVNC 2011
- Status last verified
- Nov 2011
- First submitted
- 25 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Different Myocardial Parameters to Differentiate Left Ventricular Noncompaction Cardiomyopathy From Other Cardiomyopathies and Healthy Controls by Cardiac Magnetic Resonance
- ClinicalTrials.gov ID
- NCT01481298
- Acronym / sponsor ID
- LVNC 2011
- Conditions
- Left Ventricular Non-compaction Cardiomyopathy, Left Ventricular Failure, Left Ventricular Hypertrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 Nov 2011 (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.
Left ventricular non-compaction (LVNC) is a rare cardiomyopathy characterized by numerous excessively prominent left ventricular (LV) trabeculation and deep intertrabecular recesses communicating with the ventricular cavity and severely altering myocardial structure. Although most authors assume a developmental arrest in embryogenesis as the underlying pathology, the mechanisms of LVNC are not fully understood yet. Several gene mutations have been identified to be linked with LVNC and an autosomal dominant inheritance pattern is frequent To date the most commonly used imaging tool for diagnosing LVNC is echocardiography applying the criteria established by Jenni and coauthors However, qualitative parameters to differentiate normal compaction of the myocardium in healthy subjects from LVNC or from other cardiomyopathies like dilative cardiomyopathy (DCM) or hypertrophic cardiomyopathy (HCM) may fail due to highly variable LV trabeculation. Therefore, absolute quantification should be performed. Cardiac magnetic resonance (CMR) has been reported as a promising imaging modality to characterize patients with LVNC as it provides both a high spatial resolution and a good contrast between trabeculation and blood pool Jacquier et al. recently described a value of trabeculated LV myocardial mass above 20% of the global mass of the LV to be highly sensitive and specific for LVNC However, in their approach, a substantial degree of the LV cavity was included into calculated trabecular LV mass and led to systemic overestimation of the latter. Furthermore, the role and prognostic value of myocardial scarring as assessed by delayed enhancement (DE) CMR was not evaluated.
The aim of the retrospective study was to establish revised and extended CMR criteria to distinguish LVNC from DCM, HCM and a group of healthy controls and to improve the assessment of trabeculated mass by excluding intertrabecular blood pool.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LVNC | – | –12 patients with left ventricular non-compaction cardiomyopathy |
| HCM | – | –10 patients with hypertrophic cardiomyopathy |
| DCM | – | –11 patients with dilatative cardiomyopathy |
| controls | – | –24 healthy controls |
Who may qualify
- Ages
- 14 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Twelve patients (3 male, 27%) with proven LVNC, two with familial LVNC, were included into the study. The patients initially presented with symptoms of heart failure and were referred to the department of cardiology for further evaluation. All patients underwent echocardiography performed by experienced specialists and fulfilled the LVNC criteria of Jenni. CMR imaging was performed within 3 days after echocardiography. Exclusion criteria were co-existing cardiac anomalies and usual CMR contraindications such as implanted defibrillators/pacemakers. The investigators furthermore included 10 consecutive patients (4 male, 36%) with HCM and 11 consecutive patients (3 male, 27%) with DCM. The diagnosis of HCM and DCM was established according to current guidelines Patient parameters were compared to a control group of 25 healthy age matched volunteers (12 male, 48%) without history of cardiovascular disease and without clinical symptoms.
Key inclusion criteria (3 listed)
- left ventricular non-compaction cardiomyopathy
- dilatative cardiomyopathy
- hypertrophic cardiomyopathy or healty controls
Key exclusion criteria (1 listed)
- contraindications for magnetic resonance imaging like pacemakers or other metallic implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 29 Nov 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Non-compaction Cardiomyopathy and Left Ventricular Failure, run by University of Leipzig at 1 site in Germany.
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 3 inclusion and 1 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 29 Nov 2011. 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 Germany. 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.
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 29 Nov 2011.