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Cardiac Amyloidosis : Diagnostic Using Red Flag Signals

NCT ID: NCT04459169

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

424 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-30

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Cardiac Amyloidosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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diagnostic algorithm

Cardiac amyloidosis diagnosed according to Gillmore's algorithm

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

University Hospital Center of Martinique

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doctor INAMO Jocelyn

Role: STUDY_DIRECTOR

CHU de Martinique

Locations

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Centre Hospitalier de Basse-Terre

Basse-Terre, , Guadeloupe

Site Status NOT_YET_RECRUITING

CHU de Martinique

Fort-de-France, , Martinique

Site Status RECRUITING

CHU de Martinique

La Trinité, , Martinique

Site Status NOT_YET_RECRUITING

Countries

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Guadeloupe Martinique

Central Contacts

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Jocelyne CRASPAG, MSc

Role: CONTACT

Phone: +596596592698

Email: [email protected]

Doctor INAMO Jocelyn

Role: CONTACT

Phone: +596596306410

Email: [email protected]

Facility Contacts

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ATALLAH André, MD

Role: primary

Jocelyn INAMO, MD-PhD

Role: primary

Nathalie OZIER-LAFONTAINE, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 29972757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23984729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30747298 (View on PubMed)

Related Links

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https://www.em-consulte.com/article/1192918/article/frequency-of-cardiac-amyloidosis-inpatients-with-u

Frequency of cardiac amyloidosis inpatients with unexplained left ventricular hypertrophy: The Caribbean Amyloidosis Study

Other Identifiers

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18_RIPH2-22

Identifier Type: -

Identifier Source: org_study_id