Clinical trial NCT03134898: Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
Official title: Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Pulmonary Thromboembolisms
Lead sponsor: Sociedad Española de Neumología y Cirugía Torácica
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 1025
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with diagnosis of incidental or symptomatic pulmonary thromboembolisms

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).

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.

Eligibility 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

Primary outcomes:
measure: Pulmonary hypertension
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital U. Central. de Asturias
state: Asturias
city: Badalona
country: Spain
facility: Hospital M. de Badalona
state: Barcelona
city: Badalona
country: Spain
facility: Hospital U. German Trias i Pujol
state: Barcelona
city: Sant Cugat del Valles
country: Spain
facility: Hospital G. de Cataluña
state: Barcelona
city: Viladecans
country: Spain
facility: Hospital de Viladecans
state: Barcelona
city: Santander
country: Spain
facility: Hospital U. Marqués de Valdecilla
state: Cantabria
city: Torrelavega
country: Spain
facility: Hospital Sierrallana
state: Cantabria
city: Bilbao
country: Spain
facility: Hospital de Cruces
state: Guipuzcua
city: Logrono
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Alcorcón
country: Spain
facility: Hospital U. Fundación Alcorcón
state: Madrid
city: Getafe
country: Spain
facility: Hospital U. de Getafe
state: Madrid
city: Pamplona
country: Spain
facility: Hospital Virgen del Camino
state: Navarra
city: Seville
country: Spain
facility: Hospital Virgen del Rocío
state: Sevilla
city: Galdacano
country: Spain
facility: Hospital Galdakao-Usansolo
state: Vizcaya
city: Alava
country: Spain
facility: Hospital de Araba
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Gerona
country: Spain
facility: Hospital U. de Girona Doctor Josep Trueta
city: Granada
country: Spain
facility: Hospital U. Virgen de las Nieves
city: Madrid
country: Spain
facility: Hospital U. La Paz
city: Madrid
country: Spain
facility: Hospital U. Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital San Juan de Dios
city: Valladolid
country: Spain
facility: Hospital C. U. de Valladolid
city: Zaragoza
country: Spain
facility: Hospital C. U. Lozano Blesa
Study officials:
affiliation: Hospital Universitario Virgen del Rocío IBIS
name: Remedios Otero Candelera
role: STUDY_CHAIR
References:
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: 10.4414/smw.2008.11915.
citation: Lang IM. Chronic thromboembolic pulmonary hypertension--not so rare after all. N Engl J Med. 2004 May 27;350(22):2236-8. doi: 10.1056/NEJMp048088. No abstract available.
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.
citation: 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.
citation: Galie N, Kim NH. Pulmonary microvascular disease in chronic thromboembolic pulmonary hypertension. Proc Am Thorac Soc. 2006 Sep;3(7):571-6. doi: 10.1513/pats.200605-113LR.