Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

Cardiac Amyloidosis Clinical Trial

— TEAM Red Flags  

Official title:

Early Echographic Screening of Cardiac Amyloidosis Using Red Flag Signals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04459169
• Other study ID #: 18_RIPH2-22
• Status: Recruiting
• Start date: September 30, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2020
• Source: University Hospital Center of Martinique
• Contact: Jocelyne CRASPAG, MSc
• Phone: +596596592698
• Email: jocelyne.craspag[@]chu-martinique.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 424
• Est. completion date: December 31, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiac Amyloidosis

Intervention

Procedure:
• diagnostic algorithm
Cardiac amyloidosis diagnosed according to Gillmore's algorithm

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Center of Martinique	Pfizer

Countries where clinical trial is conducted

Guadeloupe,  Martinique, 

References & Publications (3)

Benson MD, Waddington-Cruz M, Berk JL, Polydefkis M, Dyck PJ, Wang AK, Planté-Bordeneuve V, Barroso FA, Merlini G, Obici L, Scheinberg M, Brannagan TH 3rd, Litchy WJ, Whelan C, Drachman BM, Adams D, Heitner SB, Conceição 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm	frequency of cardiac amyloidosis diagnosed according to Gillmore's algorithm at the end of the diagnosis procedures, using biological (presence of cell dyscrasia), imaging (myocardial staining of bone tracers), and tissue examination (Congo Red staining) variables	3 months
Secondary	Frequency genotype of Transthyretin cardiac amyloidosis according to Gillmore's algorithm	Evaluate the frequency of Transthyretin cardiac amyloidosis among subjects with even moderate left ventricular enlargement (wall thickness = 12 mm), taking into account the presence or not of Red Flag signals	5 months
Secondary	Distribution of Red Flag signals according to Transthyretin genotype	To Compare the distribution of Red Flag signals between wild type TTR cardiac amyloidosis and hereditary TTR cardiac amyloidosis	5 months
Secondary	Diagnosis value of any Red Flag signal.	To evaluate the diagnostic performance of each of the Red Flag signals for the diagnosis of TTR cardiac amyloidosis	5 months
Secondary	Elaboration of a pre-test probability score	To elaborate a pre-test probability score including the Red Flag signals, adapted to the Echo Lab settings.	5 months

External Links

•   Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study
•   Patisiran, an RNAi Therapeutic, for Hereditary Transthyretin Amyloidosis