Clinical trial NCT04459169: Cardiac Amyloidosis : Diagnostic Using Red Flag Signals
Official title: Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Amyloidosis
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2020-07-07
Enrollment: 424
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Caribbeans who the large share of populations from African origin may be associated with a high prevalence of Transthyretin amyloidosis.

In this population, diagnosis procedure will be perform to any patient with Left Ventricular Hypertrophy (LVH) with wall thickness ≥ 12 mm associated with clinical manifestations (or Red Flag signals

Brief summary: Cardiac amyloidosis is an increasingly contributor of degenerative cardiac diseases. However, its frequency remains underestimated, and diagnosis is often realized at late stages of the disease. A larger use of clinical and echographic Red Flag signals during routine echocardiographic examination may enhance the identification of early stage of the disease.

Detailed description: The objective is to evaluate the clinical and epidemiological aspects of cardiac amyloidosis using a systematic screening of even moderate left ventricular hypertrophy, taking into account the presence of Red Flag signals. Red Flag Signals will include history or symptoms of carpal tunnel syndrome, hearing loss, chronic gastrointestinal disorders, heart failure, cervical or lumbar stenosis, or echographic abnormalities such as apical sparring, increased left ventricular filling pressure, atrio-ventricular block.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of left ventricular hypertrophy defined by a parietal thickness (interventricular septum or posterior wall) ≥ 12 mm on the echocardiogram
2. Age equal or greater than 45 years
3. Current residency in Martinique, Guadeloupe or French Guyana
4. Ability to receive and understand research information
5. Ability to freely deliver informed written consent

Exclusion Criteria:

1. Pregnant or breastfeeding woman
2. Severe uncontrolled hypertension
3. Chronic hemodialysis
4. Person under legal protection measures (guardianship, curatorship, safeguard of justice), and person deprived of liberty

Primary outcomes:
measure: Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm
timeFrame: 3 months
Secondary outcomes:
measure: Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm
timeFrame: 5 months
measure: Distribution of Red Flag signals according to Transthyretin genotype
timeFrame: 5 months
measure: Diagnosis value of any Red Flag signal.
timeFrame: 5 months
measure: Elaboration of a pre-test probability score
timeFrame: 5 months
Other outcomes:
Locations:
city: Basse-Terre
country: Guadeloupe
facility: Centre Hospitalier de Basse-Terre
city: Fort-de-France
country: Martinique
facility: CHU de Martinique
city: La Trinité
country: Martinique
facility: CHU de Martinique
Study officials:
affiliation: CHU de Martinique
name: Doctor INAMO Jocelyn
role: STUDY_DIRECTOR
References:
citation: Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Plante-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceicao I, Schmidt HH, Vita G, Campistol JM, Gamez J, Gorevic PD, Gane E, Shah AM, Solomon SD, Monia BP, Hughes SG, Kwoh TJ, McEvoy BW, Jung SW, Baker BF, Ackermann EJ, Gertz MA, Coelho T. Inotersen Treatment for Patients with Hereditary Transthyretin Amyloidosis. N Engl J Med. 2018 Jul 5;379(1):22-31. doi: 10.1056/NEJMoa1716793.
citation: Coelho T, Adams D, Silva A, Lozeron P, Hawkins PN, Mant T, Perez J, Chiesa J, Warrington S, Tranter E, Munisamy M, Falzone R, Harrop J, Cehelsky J, Bettencourt BR, Geissler M, Butler JS, Sehgal A, Meyers RE, Chen Q, Borland T, Hutabarat RM, Clausen VA, Alvarez R, Fitzgerald K, Gamba-Vitalo C, Nochur SV, Vaishnaw AK, Sah DW, Gollob JA, Suhr OB. Safety and efficacy of RNAi therapy for transthyretin amyloidosis. N Engl J Med. 2013 Aug 29;369(9):819-29. doi: 10.1056/NEJMoa1208760.
citation: Di Nunzio D, Recupero A, de Gregorio C, Zito C, Carerj S, Di Bella G. Echocardiographic Findings in Cardiac Amyloidosis: Inside Two-Dimensional, Doppler, and Strain Imaging. Curr Cardiol Rep. 2019 Feb 12;21(2):7. doi: 10.1007/s11886-019-1094-z.