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Institutional Registry of Haemorrhagic Hereditary Telangiectasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01761981
Recruitment Status : Unknown
Verified December 2015 by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
First Posted : January 7, 2013
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

Study Description
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Brief Summary:

The purpose of this study is to create an institutional and population-based registry of Haemorrhagic Hereditary Telangiectasia with a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival.

This study will also describe the occurrence of Haemorrhagic Hereditary Telangiectasia in the population of HIBA in the Central Hospital, as well as the characteristics of clinical presentation and evolution.


Condition or disease
Haemorrhagic Hereditary Telangiectasia

Detailed Description:

Haemorrhagic Hereditary Telangiectasia is a uncommon autosomic hereditary disorder caracterizad for recurrent epistaxis,cutaneomucous telangiectasias and arteriovenous malformations in diferent organs; brain, lung, liver and gastrointestinal are more often afected . Afect one in 5000-8000 individual in worldwide. HHT may produce important morbidity like brain absces, stroke, hemoptisis and cronic ferropenic anemia.

Molecular mechanism of this disorder are complex and still no fully dilucidated. The genes mutated in HHT encode endothelial cell-expressed proteins that mediate signalling by the transforming growth factor (TGF)b superfamily. Endoglin (HHT type I) and ACVRL-1 (HHT type 2) mutations are responsible in more than 80% of the individuals. Mutation of SMAD 4 protein (MADH4)cause HHT in association with juvenile polyposis. HHT may associated with primary pulmonary hypertension en more rare cases.

There arent HHT register in Argentina and Latinamerican population. This registry may gader valious information in order to generate a better diagnosis and treatment of our population and others.

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Institutional Registry of Haemorrhagic Hereditary Telangiectasia
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. morbidity [ Time Frame: 1 year ]
    Control visit every three month


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Haemorrhagic Hereditary Telangiectasia
Criteria

Inclusion Criteria:

  1. Patients with HHT defined.
  2. Followed in Unidad HHT of Hospital Italiano de Buenos Aires.

Exclusion Criteria:

1. Denied to participated in the registry or inform consent process.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761981


Contacts
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Contact: Marcelo M Serra, MD +541149590200 ext 4419 marcelo.serra@hospitalitaliano.org.ar
Contact: Diego H Giunta, MD +541149590200 ext 4419 diego.giunta@hospitalitaliano.org.ar

Locations
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Argentina
Hospital Italiano de Buenos Aires Recruiting
Buenos Aires, Argentina, 1081
Contact: Marcelo M Serra, MD    +541149590200 ext 4419    marcelo.serra@hospitalitaliano.org.ar   
Contact: Diego H Giunta, MD    +541149590200 ext 4419    diego.giunta@hospitalitaliano.org.ar   
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Principal Investigator: Marcelo M Serra, MD HHT Center of Excelence Hospital Italiano de Buenos Aires
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Diego Hernan Giunta, MD, Marcelo Martin Serra, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT01761981    
Other Study ID Numbers: 1900
First Posted: January 7, 2013    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Keywords provided by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires:
Haemorrhagic Hereditary Telangiectasia
Rendu Osler Weber Syndrome
Osler Weber Rendu Syndrome
HHT
Additional relevant MeSH terms:
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Telangiectasis
Vascular Diseases
Cardiovascular Diseases