Clinical trial NCT03322319: Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)
Official title: acTive scrEening of cArdiac aMyloidosis in the Caribbean's
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Ventricular Hypertrophy
Keywords: Cardiac amyloidosis
Caribbean
Diagnosis
Transthyretin
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years,
* Residency in French Caribbean Regions
* Access to healthcare coverage,
* Written informed consent obtained

Exclusion Criteria:

* 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

Primary outcomes:
measure: Diagnosis of cardiac amyloidosis.
timeFrame: 3 months
Secondary outcomes:
measure: Subtyping of cardiac amyloidosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Basse-Terre
country: Guadeloupe
facility: Centre Hospitalier de Basse-Terre
city: La Trinité
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: Centre Hospitalier Universitaire de Martinique, France
name: Jocelyn INAMO, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.