Last updated on February 2018

Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension


Brief description of study

The current data on the incidence of pulmonary hypertension (PH) are very variable, depending on the different studies designs. There are no data on the prognostic of PH in patients with asymptomatic pulmonary thromboembolisms (PT), neither paucisymptomatic PH, in which without a prospective follow-up would be underdiagnosed. We thought that the prognosis of both clinical forms (PT with or without symptoms) would be similar.

The objective of this study is know the real incidence of pulmonary hypertension (PH) post symptomatic and asymptomatic pulmonary thromboembolic (PT).

Detailed Study Description

Rationale

Pulmonary hypertension (PH) post pulmonary thromboembolisms is a serious and complex disease, is one major cause of pulmonary hypertension (1). It is the most feared late complication of pulmonary thromboembolism (PT) characterized by the organization of thrombotic material within the pulmonary arteries (2). Although a purely mechanical theory is too simplistic in view of the lack of correlation between the proportion of obliterated pulmonary arteries and the numbers of PH.

Acute, symptomatic, or asymptomatic PT may be the initial event, but disease progression would result from progressive vascular remodeling of small vessels. It is possible that unresolved pulmonary arterial thrombosis is a decisive factor for vascular endothelial cells to initiate their mesenchymal transition (3).

On the other hand, Pulmonary hypertension post pulmonary thromboembolisms is the only subclass of pulmonary hypertension that has a curative surgical treatment (4). The diagnosis of this situation should be detected as soon as possible to optimize the results of surgical and pharmacological treatment. Surgical indication should be established as early as possible to avoid progression (5).

Hypothesis

The current data on the incidence of PH are very variable, depending on the different studies designs. There are no data on the prognostic of PH in patients with asymptomatic PT, neither paucisymptomatic PH, in which without a prospective follow-up would be underdiagnosed. We thought that the prognosis of both clinical forms (PT with or without symptoms) would be similar. Also we thought and that there are forms of paucisymptomatic PH whose diagnosis and treatment would benefit from a prospective follow-up.

Objectives

Main objective

To know the incidence of pulmonary hypertension (PH) post symptomatic and asymptomatic pulmonary thromboembolic (PT).

The secondary objectives of the study are:

  • To defined clinical subtypes of PT with a predictive value of diagnosis of PH in two years.
  • To Measure biomarkers described that may be related to the diagnosis of PH or the disease progression.
  • Use of genetic, proteomic, RNA transcription, cytometric and cellular and metabolic identification assays to aid in the search for new genetic factors and / or PH biomarkers.

Clinical Study Identifier: NCT03134898

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Pedro Bedate Díaz

Hospital U. Central. de Asturias
Oviedo, Spain
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Juan Carlos Sahuquillo Llamas

Hospital M. de Badalona
Badalona, Spain
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Manuel Monreal Bosch

Hospital U. German Trias i Pujol
Badalona, Spain
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Fátima del Molino Sanz

Hospital G. de Catalu a
Sant Cugat del Valles, Spain
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Mariano Valdés Oliveras

Hospital de Viladecans
Viladecans, Spain
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Ramón Agüero Balbín

Hospital U. Marqu s de Valdecilla
Santander, Spain
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Bernad Sierra Valle

Hospital Sierrallana
Torrelavega, Spain
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Fernando Uresandi Romero

Hospital de Cruces
Bilbao, Spain
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Mercedes Alcalde Manero

Hospital San Pedro
Logrono, Spain
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Mercedes Izquierdo Patrón

Hospital U. Fundaci n Alcorc n
Alcorcón, Spain
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María Antonia Juretschke Moragues

Hospital U. de Getafe
Getafe, Spain
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Gregorio Tiberio López

Hospital Virgen del Camino
Pamplona, Spain
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Remedios Otero Candelera

Hospital Virgen del Roc o
Seville, Spain
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Aitor Ballaz Quincoces

Hospital Galdakao-Usansolo
Galdacano, Spain
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José Luis Lobo Beristaín

Hospital de Araba
Alava, Spain
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Diego Agustín Rodriguez

Hospital del Mar
Barcelona, Spain
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Fernando García Bragado

Hospital U. de Girona Doctor Josep Trueta
Gerona, Spain
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Ignacio Casado Moreno

Hospital U. Virgen de las Nieves
Granada, Spain
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María del Carmen Fernández Capitán

Hospital U. La Paz
Madrid, Spain
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David Jiménez Castro

Hospital U. Ram n y Cajal
Madrid, Spain
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Consolación Rodríguez Matute

Hospital San Juan de Dios
Sevilla, Spain
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Agueda Herrero López

Hospital C. U. de Valladolid
Valladolid, Spain
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Francisco Conget López

Hospital C. U. Lozano Blesa
Zaragoza, Spain
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Recruitment Status: Open


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