NCT01347047

Brief Summary

  • risk factors
  • diagnosis
  • prognosis
  • treatment
  • monitoring
  • survival
  • Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de Buenos Aires.
  • Describe the characteristics of clinical presentation, evolution and predisposing factors of amyloidosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

April 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2011

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

15.3 years

First QC Date

May 2, 2011

Last Update Submit

July 17, 2026

Conditions

Amyloidosis

Keywords

AmyloidosisKnown or Suspectedrare diseases

Outcome Measures

Primary Outcomes (4)

  • Epidemiologic characteristics

    Survival anual

    From inclusion date (daignosis) until the date of death from any cause or date of last follow up(if not dead) assessed up to 10 years

  • Epidemiologic characteristics

    Organ response

    From treatment date until the date of best organ response or documented progression or date of death from any cause, whichever came first, assessed up to 10 years

  • From treatment to folow up, annualy

    Baseline description

    at baseline

  • Treatment patterns

    Type of treatment, duration, adverse events, completition

    From diagnosis, evaluated after every line of treatment or annualy up to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults over 18 years old with diagnosis or suspected amyloidosis of Italiano Hospital of Buenos Aires

You may qualify if:

  • Patients over 18 years:
  • Confirmed amyloidosis: Proof of deposit of amyloid pathology by tissue biopsy in abdominal fat, bone marrow, rectum or organ involved (eg, kidney, liver, sural nerve)
  • Clinically compatible case of Amyloidosis :

You may not qualify if:

  • Refusal to participate in the study or the informed consent process by the patient or legal representative or refusal to consent to participate in the study in the case of minors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Italiano de Buenos Aires

Buenos Aires, Buenos Aires, C1199, Argentina

Location

Related Publications (13)

  • Decotto S, Domenech P, Blanco R, Rossi E, Posadas-Martinez ML, Carretero M, Aguirre A, Nucifora E, Brulc E, Falconi M, Pizarro R, Perez de Arenaza D. The role of nutritional status, measured by serum albumin, as a prognostic factor in wild-type transthyretin amyloidosis. Acta Cardiol. 2026 Jun;81(4):539-545. doi: 10.1080/00015385.2026.2669696. Epub 2026 May 8.

    PMID: 42102288RESULT

  • Vaena M, Aguirre MA, Epstein T, Schalum A, Hilbert FE, Posadas-Martinez ML, Carretero M. Days alive and out of hospital in patients with wild type transthyretin amyloidosis: cohort study. Sci Rep. 2025 Aug 19;15(1):30396. doi: 10.1038/s41598-025-14526-7.

    PMID: 40830173RESULT

  • Decotto S, Corna G, Villanueva E, Arenaza DP, Seropian I, Falconi M, Oberti P, Aguirre MA, Posadas-Martinez ML, Carretero M, Agatiello CR, Pizarro R. Prevalence of moderate-severe aortic stenosis in patients with cardiac amyloidosis in a referral center. Arch Cardiol Mex. 2024;94(1):71-78. doi: 10.24875/ACM.22000074.

    PMID: 38507302RESULT

  • Decotto S, Iroulart JM, Roveda G, Villanueva E, Aguirre MA, Posadas-Martinez ML, Nucifora E, Pizarro R, Perez de Arenaza D. Significant tricuspid regurgitation is associated with adverse outcomes in patients with transthyretin amyloid cardiomyopathy. Arch Peru Cardiol Cir Cardiovasc. 2024 Jun 24;5(2):e388. doi: 10.47487/apcyccv.v5i2.388. eCollection 2024 Apr-Jun.

    PMID: 39015189RESULT

  • Perez Lloveras E, Decotto S, Villanueva E, Marco MA, Carretero M, Posadas-Martinez ML, Perez De Arenaza D, Nucifora E, Aguirre MA. [Heart failure secondary to amyloidosis AL: diagnosis and treatment]. Medicina (B Aires). 2023;83(5):811-815. Spanish.

    PMID: 37870341RESULT

  • Villanueva E, Carretero M, Aguirre MA, Negro A, Belziti CA, Posadas-Martinez ML, Nucifora EM, Baratta S, Costabel JP, Higa C, Rivas C, Fernandez A, Quiroga A, Dumont CA, Volberg VI, Streitenberg GM, Perez de Arenaza D. [Specific pharmacological treatment guide for transthyretin amyloid cardiomyopathy, 2021]. Medicina (B Aires). 2022;82(2):275-288. Spanish.

    PMID: 35417392RESULT

  • Carretero M, Saez MS, Posadas-Martinez ML, Aguirre MA, Sorroche P, Negro A, Calandra CR, Salutto V, Lautre A, Conti E, Leon-Cejas L, Reisin R, Nucifora EM, Rugiero M. [Practice guideline for the treatment of familial amyloid polyneuropathy]. Medicina (B Aires). 2022;82(2):262-274. Spanish.

    PMID: 35417391RESULT

  • Saez MS, Aguirre MA, Perez de Arenaza D, Sorroche P, Nucifora E, Posadas Martinez ML. Epidemiology of variant transthyretin amyloidosis at a reference center in Argentina. Mol Genet Genomic Med. 2021 Nov;9(11):e1812. doi: 10.1002/mgg3.1812. Epub 2021 Oct 20.

    PMID: 34668655RESULT

  • Alfonsin AE, Escada SS, Kohan D, Valeo Chulvi MP, Posadas Martinez ML, Aguirre MA, Nucifora EM. [Transdisciplinarity in the approach to amyloidosis]. Rev Fac Cien Med Univ Nac Cordoba. 2021 Sep 18;78(3):313-316. doi: 10.31053/1853.0605.v78.n3.32341. Spanish.

    PMID: 34617706RESULT

  • Nucifora EM, Aguirre MA, Sorroche P, Saez MS, Fantl D, Rocca JA, Perez de Arenaza D, Varela CF, Greloni G, Garcia Rivello H, Basquiera AL, Alberbide JA, Giunta DH, Boietti BR, Posadas Martinez ML. AL amyloidosis in Argentina: hospital Italiano de Buenos Aires. Amyloid. 2019;26(sup1):99-100. doi: 10.1080/13506129.2019.1582485. No abstract available.

    PMID: 31343332RESULT

  • Aguirre MA, Boietti BR, Nucifora E, Luxardo R, Sorroche P, Saez S, Giunta DH, Posadas-Martinez ML. [AA amyloidosis. A single institution cohort study]. Medicina (B Aires). 2019;79(4):276-279. Spanish.

    PMID: 31487247RESULT

  • Aguirre MA, Nucifora EM, Rugiero M, Sorroche P, Saez MS, Giunta DH, Posadas-Martinez ML, Boietti BR. Transthyretin-related hereditary amyloidosis in an Argentinian family with TTR Tyr114Cys mutation. Amyloid. 2017 Mar;24(sup1):102. doi: 10.1080/13506129.2017.1291422. No abstract available.

    PMID: 28434328RESULT

  • Aguirre MA, Boietti BR, Nucifora E, Sorroche PB, Gonzalez Bernaldo de Quiros F, Giunta DH, Posadas-Martinez ML. Incidence rate of amyloidosis in patients from a medical care program in Buenos Aires, Argentina: a prospective cohort. Amyloid. 2016 Sep;23(3):184-187. doi: 10.1080/13506129.2016.1207626. Epub 2016 Jul 28.

    PMID: 27470486RESULT

MeSH Terms

Conditions

AmyloidosisRare Diseases

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • María Lourdes Posadas-Martínez, MD

    Hospital Italiano de Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Elsa Nucifora, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Diego Hernan Giunta, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Dorotea Fantl, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Gustavo Greloni, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Maria Adela Aguirre, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Cesar Antonio Belziti, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Patricia Sorroche

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Soledad Saez

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Erika Brulc, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Diego Perez de Arenaza, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Eugenia Villanueva, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Marcelina Carretero, MD

    Hospital Italiano de Buenos Aires, Argentina

    STUDY CHAIR

  • Carolina María Petit Cwirko, MD

    Clinica Foianini, Santa Cruz, Bolivia

    PRINCIPAL INVESTIGATOR

  • Pablo Young, MD

    Hospital Británico, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Gisela Streitenberger, MD

    Hospital de Alta Complejidad El Cruce Nestor Kirchner, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Luciana Leon Cejas, MD

    Hospital Británico, Buenos Aires, Argentina

    STUDY CHAIR

  • Veronica Volberg, MD

    Hospital de Clínicas José de San Martin, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Sergio Juan Baratta, MD

    Hospital Austral, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Juan Pablo Costabel, MD

    Instituto cardiovascular Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Carlos Dumont Dunayevich, MD

    Hospital Privado de Rosario, Santa Fe, Argentina

    PRINCIPAL INVESTIGATOR

  • Alejandro Quiroga, MD

    Fundación Favaloro, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Adrian Fernandez, MD

    Fundación Favaloro, Buenos Aires, Argentina

    STUDY CHAIR

  • Josefina Parodi, MD

    Anchorena, Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

  • Franco Leoni, MD

    Médica Uruguaya, Uruguay

    STUDY DIRECTOR

  • Eduardo Ortuño Campos, MD

    Hospital Universitarios Austral, Buenos Aires, Argentina

    STUDY DIRECTOR

  • Jorge Thierer, MD

    CEMIC, , Buenos Aires, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PHD

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 4, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2026

Study Completion

July 1, 2026

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)