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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03134898
• Other study ID #: OSIRIS
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Embolism
• Pulmonary Hypertension
• Pulmonary Thromboembolisms
• Thromboembolism

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