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

Left Ventricular Hypertrophy Clinical Trial

Official title:

acTive scrEening of cArdiac aMyloidosis in the Caribbean's

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03322319
• Other study ID #: 12/B/17
• Status: Completed
• Phase: N/A
• First received: October 23, 2017
• Last updated: October 26, 2017
• Start date: September 23, 2013
• Est. completion date: January 18, 2016

Study information

• Verified date: October 2017
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: January 18, 2016
• Est. primary completion date: December 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Hypertrophy
• Hypertrophy, Left Ventricular
• Left Ventricular Hypertrophy

Intervention

Procedure:
• Tissue biopsies
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).

Locations

Country	Name	City	State
Guadeloupe	Centre Hospitalier de Basse-Terre	Basse-Terre
Martinique	CHU de Martinique	La Trinité

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

References & Publications (1)

Oliveira Da Silva L, Fabre J, Monfort A, Villeret J, Citony I, Cohen-Tenoudji P, Lebbadi M, Martin D, Molinié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of cardiac amyloidosis.	Diagnosis procedures involve clinical exam, echocardiography, MRI, SPECT, tissue biopsies, and will be realized following a diagnostic tree.	3 months
Secondary	Subtyping of cardiac amyloidosis	To refine the genetic epidemiology of cardiac amyloidosis in the Caribbean's	2 years