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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03134898
Other study ID # OSIRIS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 24, 2013
Est. completion date July 30, 2019

Study information

Verified date March 2021
Source Sociedad Española de Neumología y Cirugía Torácica
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 1025
Est. completion date July 30, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
Spain Hospital de Araba Alava
Spain Hospital U. Fundación Alcorcón Alcorcón Madrid
Spain Hospital M. de Badalona Badalona Barcelona
Spain Hospital U. German Trias i Pujol Badalona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital de Cruces Bilbao Guipuzcua
Spain Hospital Galdakao-Usansolo Galdacano Vizcaya
Spain Hospital U. de Girona Doctor Josep Trueta Gerona
Spain Hospital U. de Getafe Getafe Madrid
Spain Hospital U. Virgen de las Nieves Granada
Spain Hospital San Pedro Logrono La Rioja
Spain Hospital U. La Paz Madrid
Spain Hospital U. Ramón y Cajal Madrid
Spain Hospital U. Central. de Asturias Oviedo Asturias
Spain Hospital Virgen del Camino Pamplona Navarra
Spain Hospital G. de Cataluña Sant Cugat del Valles Barcelona
Spain Hospital U. Marqués de Valdecilla Santander Cantabria
Spain Hospital San Juan de Dios Sevilla
Spain Hospital Virgen del Rocío Seville Sevilla
Spain Hospital Sierrallana Torrelavega Cantabria
Spain Hospital C. U. de Valladolid Valladolid
Spain Hospital de Viladecans Viladecans Barcelona
Spain Hospital C. U. Lozano Blesa Zaragoza

Sponsors (1)

Lead Sponsor Collaborator
Sociedad Española de Neumología y Cirugía Torácica

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Condliffe R, Kiely DG, Gibbs JS, Corris PA, Peacock AJ, Jenkins DP, Hodgkins D, Goldsmith K, Hughes RJ, Sheares K, Tsui SS, Armstrong IJ, Torpy C, Crackett R, Carlin CM, Das C, Coghlan JG, Pepke-Zaba J. Improved outcomes in medically and surgically treated chronic thromboembolic pulmonary hypertension. Am J Respir Crit Care Med. 2008 May 15;177(10):1122-7. doi: 10.1164/rccm.200712-1841OC. Epub 2008 Feb 21. — View Citation

Galiè N, Kim NH. Pulmonary microvascular disease in chronic thromboembolic pulmonary hypertension. Proc Am Thorac Soc. 2006 Sep;3(7):571-6. Review. — View Citation

Humbert M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev. 2010 Mar;19(115):59-63. doi: 10.1183/09059180.00007309. Review. — View Citation

Lang IM. Chronic thromboembolic pulmonary hypertension--not so rare after all. N Engl J Med. 2004 May 27;350(22):2236-8. — View Citation

Tueller C, Stricker H, Soccal P, Tamm M, Aubert JD, Maggiorini M, Zwahlen M, Nicod L; Swiss Society for Pulmonary Hypertension. Epidemiology of pulmonary hypertension: new data from the Swiss registry. Swiss Med Wkly. 2008 Jun 28;138(25-26):379-84. doi: 2008/25/smw-11915. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary hypertension Diagnosis on pulmonary hypertension after pulmonary thromboembolism 2 years
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