Left Ventricular HypertrophyNCT03322319
Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)
A study testing Tissue biopsies in people with Left Ventricular Hypertrophy, run by University Hospital Center of Martinique at 2 sites in 2 countries.
Trial summary
The frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Hypertrophy
- What is being tested?
- Tissue biopsies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 23 Sep 2013to 18 Jan 2016
- 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
- Age > 18 years,
- Residency in French Caribbean Regions
- Access to healthcare coverage,
- Written informed consent obtained
Who cannot join
- Evidence of another cause for left ventricular hypertrophy (uncontrolled severe high blood pressure, untreated severe aortic stenosis, family history of hypertrophic cardiomyopathy)
- Inability to deliver informed consent,
- Presence of a known severe disease impending participation in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: acTive scrEening of cArdiac aMyloidosis in the Caribbean's
The frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.
Read the detailed description
Cardiac amyloidosis is a very poorly known disease, in its frequency, its mechanisms, its treatment. This lack of knowledge is a major limitation to the improvement, indispensable, of the care of the patients. In clinical routine, particularly in West Indies-Guyana, cardiac amyloidosis is a disease poorly identified, whose management remains to be optimized. Concordant observations suggest that the frequency of the disease could be significant in the Antilles-Guyana: aging of the population, high frequency of an amyloidogenic mutation (Val122Il mutation of the transthyretin gene) found in 4% of the Afro-American population, recent identification in Martinique by a neurology team of a new founding mutation of the transthyretin gene that may cause the disease.
These elements justified the setting up of a multidisciplinary group whose objective is to contribute to the improvement of screening, treatment, and follow-up of patients with cardiac amyloidosis.
An identical diagnostic algorithm will be followed in all centers. Therapeutic management will be left to the discretion of the health care teams, who will be communicated regularly, the latest management recommendations.
A frequency of 30% is expected and will be assessed with a power of 80% and an alpha risk of 0.05. Quantitative and qualitative data will be described as usual. Differences between groups will be assessed with parametric or non-parametric tests.
- Conditions
- Left Ventricular Hypertrophy
- Being tested
- Tissue biopsies
- Keywords
- Cardiac amyloidosis, Caribbean, Diagnosis, Transthyretin
- Medical subject headings
- Hypertrophy, Left Ventricular, Amyloid Neuropathies, Familial, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue biopsiesProcedure or surgery
It is commonly accepted that the diagnosis of cardiac amyloidosis may be based on presence of characteristic cardiac abnormalities in echography, associated with the detection of bi-refractive appearance deposits in polarized light after congo red staining of a biopsy fragment.
Usually a biopsy of the abdominal fat or salivary glands can suffice. More rarely, in case of persistent doubt (eg negativity of congo red despite a characteristic appearance, which may occur in 20 to 30% of cases), it will be necessary to perform an endomyocardial biopsy (EMB).
| Study group | Role | What they receive |
|---|---|---|
| left Ventricular Hypertrophy | Experimental | Patients with left ventricular wall thickness measuring 15mm or more, or patients with a suggestive left ventricular echogenicity. Procedure/surgery will be performed following a diagnostic tree. Receives: Procedure: Tissue biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of cardiac amyloidosis.
Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.
Measured: 3 months
Secondary outcomes (1)
Subtyping of cardiac amyloidosis
To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start23 Sep 2013
- Primary completion2 Dec 2015
- Study completion18 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular HypertrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jocelyn INAMO, MD-PhD, Principal investigator, Centre Hospitalier Universitaire de Martinique, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322319
- Sponsor's protocol ID
- 12/B/17
- Status last verified
- Oct 2017
- First submitted
- 23 Oct 2017
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication.
Publications
Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinie V, Inamo J. 'Green Apple' Heart Failure. West Indian Med J. 2014 Jul 3;63(6):673-5. doi: 10.7727/wimj.2013.255. Epub 2014 Jun 25.
PubMed 25803389
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- acTive scrEening of cArdiac aMyloidosis in the Caribbean's
- ClinicalTrials.gov ID
- NCT03322319
- Acronym / sponsor ID
- 12/B/17
- Conditions
- Left Ventricular Hypertrophy
- Keywords
- Cardiac amyloidosis, Caribbean, Diagnosis, Transthyretin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 2 Dec 2015 (actual)
- Study completion
- 18 Jan 2016 (actual)
- First posted
- 26 Oct 2017 (actual)
- 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 frequency of cardiac amyloidosis among patients presenting with a so-called left ventricular hypertrophy remains unknown. This problem is especially relevant in the Caribbean's, where an amyloidosis-prone mutation of transthyretin gene might be frequent.
Detailed description
Cardiac amyloidosis is a very poorly known disease, in its frequency, its mechanisms, its treatment. This lack of knowledge is a major limitation to the improvement, indispensable, of the care of the patients. In clinical routine, particularly in West Indies-Guyana, cardiac amyloidosis is a disease poorly identified, whose management remains to be optimized. Concordant observations suggest that the frequency of the disease could be significant in the Antilles-Guyana: aging of the population, high frequency of an amyloidogenic mutation (Val122Il mutation of the transthyretin gene) found in 4% of the Afro-American population, recent identification in Martinique by a neurology team of a new founding mutation of the transthyretin gene that may cause the disease.
These elements justified the setting up of a multidisciplinary group whose objective is to contribute to the improvement of screening, treatment, and follow-up of patients with cardiac amyloidosis.
An identical diagnostic algorithm will be followed in all centers. Therapeutic management will be left to the discretion of the health care teams, who will be communicated regularly, the latest management recommendations.
A frequency of 30% is expected and will be assessed with a power of 80% and an alpha risk of 0.05. Quantitative and qualitative data will be described as usual. Differences between groups will be assessed with parametric or non-parametric tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left Ventricular Hypertrophy | Experimental | Procedure: Tissue biopsiesPatients with left ventricular wall thickness measuring 15mm or more, or patients with a suggestive left ventricular echogenicity. Procedure/surgery will be performed following a diagnostic tree. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years,
- Residency in French Caribbean Regions
- Access to healthcare coverage,
- Written informed consent obtained
Key exclusion criteria (3 listed)
- Evidence of another cause for left ventricular hypertrophy (uncontrolled severe high blood pressure, untreated severe aortic stenosis, family history of hypertrophic cardiomyopathy)
- Inability to deliver informed consent,
- Presence of a known severe disease impending participation in the study
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 |
|---|---|---|
| Tissue biopsiesIt is commonly accepted that the diagnosis of cardiac amyloidosis may be based on presence of characteristic cardiac abnormalities in echography, associated with the detection of bi-refractive appearance deposits in polarized light after congo red staining of a biopsy fragment. Usually a biopsy of the abdominal fat or salivary glands can suffice. More rarely, in case of persistent doubt (eg negativity of congo red despite a characteristic appearance, which may occur in 20 to 30% of cases), it will be necessary to perform an endomyocardial biopsy (EMB). | Procedure or surgery | left Ventricular Hypertrophy |
Primary outcome
Diagnosis of cardiac amyloidosis.
Time frame: 3 months
Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.
1 secondary outcome
Subtyping of cardiac amyloidosis
Time frame: 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 27 Oct 2017.
- Results publication: PubMed 25803389Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinie V, Inamo J. 'Green Apple' Heart Failure. West Indian Med J. 2014 Jul 3;63(6):673-5. doi: 10.7727/wimj.2013.255. Epub 2014 Jun 25.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication.
Related trials for Left Ventricular Hypertrophy
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
Active, not recruiting
Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
Not yet recruiting
Therapeutic Implications of CMR Low Native T1 in Non-treated Non-hypertrophic Females With Fabry Disease (FD)
Fabry Disease
RecruitingPhase 2
A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease
Danon Disease
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.
Jocelyn INAMO, MD-PhD principal investigator
Centre Hospitalier Universitaire de Martinique, France
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue biopsies in people with Left Ventricular Hypertrophy, run by University Hospital Center of Martinique at 2 sites in 2 countries.
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 4 inclusion and 3 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 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guadeloupe, Martinique. 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?
Diagnosis of cardiac amyloidosis. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03322319, which also lists 1 linked publication.
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 27 Oct 2017.