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AmyloidosisRIA-HIBANCT01347047

HIBA-Institutional Registry of Amyloidosis

An observational study of Amyloidosis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. Creating a population-based registry system Amyloidosis prospective epidemiological survey risk factors diagnosis prognosis treatment monitoring survival 2. Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de Buenos Aires. 3. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Amyloidosis
How many people
500 participants
Where
1 siteArgentina
Study dates
Apr 2011to Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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 :

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site
  • Hospital Italiano de Buenos Aires

    Buenos Aires, Buenos Aires, C1199

Other trials in Argentina

About this study

Official title: Institutional Registry of Amyloidosis (Hospital Italiano de Buenos Aires)

  1. Creating a population-based registry system Amyloidosis prospective epidemiological survey
  • risk factors
  • diagnosis
  • prognosis
  • treatment
  • monitoring
  • survival
  1. Describe the occurrence of amyloidosis in the population of HIBA, Hospital Italiano de Buenos Aires.
  2. Describe the characteristics of clinical presentation, evolution and predisposing factors of amyloidosis.
Read the detailed description

Amyloidosis is a systemic disease that is usually a result of misfolded proteins in the form of amorphous fibrillar material in various tissues and can cause progressive dysfunction of the same. The prevalence of amyloidosis varies depending on the population concerned and the type of amyloid. While prevalence in the general population is unknown, according to estimates by the Mayo Clinic this prevalence is 1 in 90 666% in the U.S. In England this disease generated about 0.0084% (1367 / 16232579) of all hospital visits between April 2008 and April 2009.

The most common clinical manifestations include cardiac disease, renal and liver function, but it may vary widely depending on the type of amyloidosis, the organ infected and extent of the deposits. Amyloid infiltration can produce signs and symptoms that may be very similar to other rheumatic diseases. This may suggest potential clinical polymorphic underdiagnosis due to low clinical suspicion.

The registries are organized systems of systematic data collection of a large number of patients quickly and efficiently on a particular disease at a given time.

The main difficulty of the registries is the guarantee of the quality of their data.

The main objectives of the registry are:

  1. Understand risk factors and prognosis.
  2. Evaluate the diagnostic and therapeutic comparison with current standards.
  3. Advance knowledge of the disease to optimize the assessment, treatment and monitoring of patients.
  4. Analyze the effectiveness of new therapies.
  5. Studying differences between populations.
  6. Quickly estimate the morbidity, mortality and resource utilization associated with a disease entity.
  7. Examine the course of a disease
  8. Formulate novel hypotheses for further prospective studies. Currently, there are registries for patients with transthyretin amyloidosis (TAHOS), global registry of transplant patients with familial amyloid poly neuropathy. Also, there are indirect registries such as the kidney transplant, heart transplant, among others.

The investigators found no data on the prevalence or incidence, evolution and prognosis of amyloidosis in our country. There are no existing records of national Amyloidosis in Latin America that could describe the behavior of this disease in our environment. Because it is a chronic disease with amyloid infiltration and can produce signs and symptoms that may be very similar to other rheumatic diseases, this clinic potentially poliform, may suggest underestimation of low clinical suspicion. As there is no cure, some patients may persist symptomatic despite adequate therapy, that is why it is important the creation of a monitoring system to generate data on the evolution and prognosis. The data registries can be used to develop new treatment guidelines and recommendations, also to inform and educate physicians on the management of this disease.

The Hospital Italiano de Buenos Aires is a center of high complexity of derivation of this type of pathology and due to the fact that the hospital, that has a private health insurance system (HIBA's health plan [plan de salud, PS], gives the unique opportunity denominators for the generation of a population on their affiliates, therefore the investigators propose to make a Institutional Registry of Amyloidosis.

Conditions
Amyloidosis
Keywords
Amyloidosis, Known or Suspected, rare diseases
Medical subject headings
Amyloidosis, Rare Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Epidemiologic characteristics

    Survival anual

    Measured: 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

  2. Epidemiologic characteristics

    Organ response

    Measured: 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

  3. From treatment to folow up, annualy

    Baseline description

    Measured: at baseline

  4. Treatment patterns

    Type of treatment, duration, adverse events, completition

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJul 2026
  4. Study completionJul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347047
Sponsor's protocol ID
1675
Acronym
RIA-HIBA
Status last verified
Jul 2026
First submitted
2 May 2011
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 42102288
  • 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.

    PubMed 40830173
  • 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.

    PubMed 38507302
  • 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.

    PubMed 39015189
  • 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.

    PubMed 37870341
  • 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.

    PubMed 35417392
  • 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.

    PubMed 35417391
  • 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.

    PubMed 34668655
  • 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.

    PubMed 34617706
  • 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.

    PubMed 31343332
  • 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.

    PubMed 31487247
  • 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.

    PubMed 28434328
  • 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.

    PubMed 27470486

Questions about this trial

What is this clinical trial studying?

An observational study of Amyloidosis, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Epidemiologic characteristics (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01347047, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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