Frequency of Cardiac Amyloidosis in the Caribbean's. (TEAM Amylose)

Not Applicable

Completed

• Conditions: Left Ventricular Hypertrophy
• Interventions: Procedure: Tissue biopsies

• Registration Number: NCT03322319
• Lead Sponsor: University Hospital Center of Martinique

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.

Study Timeline

• Study Start: 2013-09-23
• Primary Completion: 2015-12-02
• Study Completion: 2016-01-18
• Status Verified: 2017-10
• Study First Submitted: 2017-10-23
• Study First Submitted QC: 2017-10-23
• Study First Posted: 2017-10-26
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
left Ventricular Hypertrophy	Tissue biopsies	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.

Primary Outcome Measures

Name	Time	Method
Diagnosis of cardiac amyloidosis.	3 months	Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.

Secondary Outcome Measures

Name	Time	Method
Subtyping of cardiac amyloidosis	2 years	To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's

Trial Locations

Locations (2)

CHU de Martinique; 🇲🇶 La Trinité, Martinique

Centre Hospitalier de Basse-Terre; 🇬🇵 Basse-Terre, Guadeloupe