NCT03322319

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

October 23, 2017

Last Update Submit

October 26, 2017

Conditions

Left Ventricular Hypertrophy

Keywords

Cardiac amyloidosisCaribbeanDiagnosisTransthyretin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subtyping of cardiac amyloidosis

    2 years

Study Arms (1)

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.

Procedure: Tissue biopsies

Interventions

Tissue biopsiesPROCEDURE

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).

left Ventricular Hypertrophy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier de Basse-Terre

Basse-Terre, 97100, Guadeloupe

Location

CHU de Martinique

La Trinité, 97220, Martinique

Location

Related Publications (1)

  • 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.

    PMID: 25803389RESULT

MeSH Terms

Conditions

Hypertrophy, Left VentricularAmyloid Neuropathies, FamilialDisease

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis DeficienciesPathologic Processes

Study Officials

  • Jocelyn INAMO, MD-PhD

    Centre Hospitalier Universitaire de Martinique, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 26, 2017

Study Start

September 23, 2013

Primary Completion

December 2, 2015

Study Completion

January 18, 2016

Last Updated

October 27, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

All collected IPD, all IPD that underlie results in a publication.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After the main publication of the results, for not limited time.
Access Criteria
The conditions for the transfer of all or part of the database of the research are decided by the investigator coordinator / sponsor of the research and are the subject of a written contract.

Locations

GU(1)MA(1)