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

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ClinicalTrials.gov Identifier: NCT03134898
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Remedios Otero Candelera, Hospitales Universitarios Virgen del Rocío

Brief Summary:

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).


Condition or disease
Pulmonary Hypertension Pulmonary Thromboembolisms

Detailed 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.

Study Type : Observational
Estimated Enrollment : 1025 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
Actual Study Start Date : November 24, 2013
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Pulmonary hypertension [ Time Frame: 2 years ]
    Diagnosis on pulmonary hypertension after pulmonary thromboembolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with diagnosis of incidental or symptomatic pulmonary thromboembolisms
Criteria

Inclusion Criteria:

  • Patients 18 years or older and able to provide informed consent
  • Diagnosis of pulmonary thromboembolisms confirmed by
  • Computed Tomography Angiography (CTA) if there are a partial transluminal defect surrounded by contrast or a complete occlusion of pulmonary artery.
  • Pulmonary ventilation/perfusion scan.- Patients with high risk based on PIOPED study criteria or in patients with deep venous thrombosis confirmed by echography and positron emission tomography (PET) scan not concluding.

Exclusion Criteria:

  • Any contraindication to the performance of the pulmonary hypertension diagnostic tests
  • Any circumstance, to investigator criteria, to impede the patient follow up
  • Life expectancy lower than 6 months

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): NCT03134898


Contacts
Contact: Emilio Cabrera emiliogcabrera@delosclinical.com

Locations
Spain
Hospital U. Central. de Asturias Recruiting
Oviedo, Asturias, Spain
Contact: Pedro Bedate Díaz         
Principal Investigator: Pedro Bedate Díaz         
Hospital M. de Badalona Recruiting
Badalona, Barcelona, Spain
Contact: Juan Carlos Sahuquillo Llamas         
Principal Investigator: Juan Carlos Sahuquillo Llamas         
Hospital U. German Trias i Pujol Recruiting
Badalona, Barcelona, Spain
Contact: Manuel Monreal Bosch         
Principal Investigator: Manuel Monreal Bosch         
Hospital G. de Cataluña Recruiting
Sant Cugat del Valles, Barcelona, Spain
Contact: Fátima del Molino Sanz         
Principal Investigator: Fátima del Molino Sanz         
Hospital de Viladecans Recruiting
Viladecans, Barcelona, Spain
Contact: Mariano Valdés Oliveras         
Principal Investigator: Mariano Valdés Oliveras         
Hospital U. Marqués de Valdecilla Recruiting
Santander, Cantabria, Spain
Contact: Ramón Agüero Balbín         
Principal Investigator: Ramón Agüero Balbín         
Hospital Sierrallana Recruiting
Torrelavega, Cantabria, Spain
Contact: Bernad Sierra Valle         
Principal Investigator: Bernad Sierra Valle         
Hospital de Cruces Recruiting
Bilbao, Guipuzcua, Spain
Contact: Fernando Uresandi Romero         
Principal Investigator: Fernando Uresandi Romero         
Hospital San Pedro Recruiting
Logrono, La Rioja, Spain
Contact: Mercedes Alcalde Manero         
Principal Investigator: Mercedes Alcalde Manero         
Sub-Investigator: Manuel Barrón Medrano         
Hospital U. Fundación Alcorcón Recruiting
Alcorcón, Madrid, Spain
Contact: Mercedes Izquierdo Patrón         
Principal Investigator: Mercedes Izquierdo Patrón         
Hospital U. de Getafe Recruiting
Getafe, Madrid, Spain
Contact: María Antonia Juretschke Moragues         
Principal Investigator: María Antonia Juretschke Moragues         
Hospital Virgen del Camino Recruiting
Pamplona, Navarra, Spain
Contact: Gregorio Tiberio López         
Principal Investigator: Gregorio Tiberio López         
Hospital Virgen del Rocío Recruiting
Seville, Sevilla, Spain, 41013
Contact: Remedios Otero Candelera         
Principal Investigator: Remedios Otero Candelera         
Hospital Galdakao-Usansolo Recruiting
Galdacano, Vizcaya, Spain
Contact: Aitor Ballaz Quincoces         
Principal Investigator: Aitor Ballaz Quincoces         
Hospital de Araba Recruiting
Alava, Spain
Contact: José Luis Lobo Beristaín         
Principal Investigator: José Luis Lobo Beristaín         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Diego Agustín Rodriguez         
Principal Investigator: Diego Agustín Rodriguez         
Hospital U. de Girona Doctor Josep Trueta Recruiting
Gerona, Spain
Contact: Fernando García Bragado         
Principal Investigator: Fernando García Bragado         
Hospital U. Virgen de las Nieves Recruiting
Granada, Spain
Contact: Ignacio Casado Moreno         
Principal Investigator: Ignacio Casado Moreno         
Hospital U. La Paz Recruiting
Madrid, Spain
Contact: María del Carmen Fernández Capitán         
Principal Investigator: María del Carmen Fernández Capitán         
Hospital U. Ramón y Cajal Recruiting
Madrid, Spain
Contact: David Jiménez Castro         
Principal Investigator: David Jiménez Castro         
Hospital San Juan de Dios Recruiting
Sevilla, Spain
Contact: Consolación Rodríguez Matute         
Principal Investigator: Consolación Rodríguez Matute         
Hospital C. U. de Valladolid Recruiting
Valladolid, Spain
Contact: Agueda Herrero López         
Principal Investigator: Agueda Herrero López         
Hospital C. U. Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Francisco Conget López         
Principal Investigator: Francisco Conget López         
Sponsors and Collaborators
Delos Clinical
Investigators
Study Chair: Remedios Otero Candelera Hospital Universitario Virgen del Rocío IBIS

Publications:
Responsible Party: Remedios Otero Candelera, MD Ph D, Hospitales Universitarios Virgen del Rocío
ClinicalTrials.gov Identifier: NCT03134898     History of Changes
Other Study ID Numbers: OSIRIS
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Thromboembolism
Pulmonary Embolism
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Embolism