Pulmonary HypertensionNCT03134898
Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
An observational study of Pulmonary Hypertension and Pulmonary Thromboembolisms, run by Sociedad Española de Neumología y Cirugía Torácica at 23 sites in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- How many people
- 1,025 participants
- Where
- 23 sitesSpain
- Study dates
- 24 Nov 2013to 30 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with diagnosis of incidental or symptomatic pulmonary thromboembolisms
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Spain23 sites
Hospital de Araba
Alava
Hospital U. Fundación Alcorcón
Alcorcón, Madrid
Hospital M. de Badalona
Badalona, Barcelona
Hospital U. German Trias i Pujol
Badalona, Barcelona
Hospital del Mar
Barcelona
Hospital de Cruces
Bilbao, Guipuzcua
Hospital Galdakao-Usansolo
Galdakao, Vizcaya
Hospital U. de Getafe
Getafe, Madrid
Hospital U. de Girona Doctor Josep Trueta
Girona
Hospital U. Virgen de las Nieves
Granada
Hospital San Pedro
Logroño, La Rioja
Hospital U. La Paz
Madrid
Hospital U. Ramón y Cajal
Madrid
Hospital U. Central. de Asturias
Oviedo, Principality of Asturias
Hospital Virgen del Camino
Pamplona, Navarre
Hospital G. de Cataluña
Sant Cugat del Vallès, Barcelona
Hospital U. Marqués de Valdecilla
Santander, Cantabria
Hospital Virgen del Rocío
Seville, Sevilla, 41013
Hospital San Juan de Dios
Seville
Hospital Sierrallana
Torrelavega, Cantabria
Hospital C. U. de Valladolid
Valladolid
Hospital de Viladecans
Viladecans, Barcelona
Hospital C. U. Lozano Blesa
Zaragoza
About this 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).
Read the 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.
- Conditions
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary hypertension
Diagnosis on pulmonary hypertension after pulmonary thromboembolism
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start24 Nov 2013
- Primary completion30 Jun 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ferran Barbe, Hospitales Universitarios Virgen del Rocío
- Investigators
- Remedios Otero Candelera, Study chair, Hospital Universitario Virgen del Rocío IBIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134898
- Sponsor's protocol ID
- OSIRIS
- Status last verified
- Mar 2021
- First submitted
- 26 Apr 2017
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18587690Lang 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.
PubMed 15163772Humbert M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev. 2010 Mar;19(115):59-63. doi: 10.1183/09059180.00007309.
PubMed 20956167Condliffe 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.
PubMed 18292468Galie 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.
PubMed 16963536Otero R, Lobo JL, Lopez R, Fernandez C, Jimenez D, Muriel A, Alfonso M, Ballaz A, Nunez-Ares A, Rodriguez-Matute C, de Miguel-Diez J, Rodriguez-Chiaradia DA, Alcalde M, Elias T, Jara-Palomares L, Rivas A, Alonso A, Garcia-Ortega A, Sancho T, Morillo R, Garcia-Bragado F, Hernandez-Blasco L, Uresandi F, Madridano O, Aguero R, Monreal M; OSIRIS Investigators. Feasibility of a screening algorithm for chronic thromboembolic pulmonary hypertension: The OSIRIS study. Thromb Res. 2023 Aug;228:1-9. doi: 10.1016/j.thromres.2023.05.005. Epub 2023 May 19.
PubMed 37263121
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study to Identify Predictive Factors of Post-thrombotic Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT03134898
- Acronym / sponsor ID
- OSIRIS
- Conditions
- Pulmonary Hypertension, Pulmonary Thromboembolisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- 24 Nov 2013 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with diagnosis of incidental or symptomatic pulmonary thromboembolisms
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulmonary hypertension
Time frame: 2 years
Diagnosis on pulmonary hypertension after pulmonary thromboembolism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Background: PubMed 18587690Tueller 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.
- Background: PubMed 15163772Lang 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.
- Background: PubMed 20956167Humbert M. Pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension: pathophysiology. Eur Respir Rev. 2010 Mar;19(115):59-63. doi: 10.1183/09059180.00007309.
- Background: PubMed 18292468Condliffe 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.
- Background: PubMed 16963536Galie 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.
- Derived from this study: PubMed 37263121Otero R, Lobo JL, Lopez R, Fernandez C, Jimenez D, Muriel A, Alfonso M, Ballaz A, Nunez-Ares A, Rodriguez-Matute C, de Miguel-Diez J, Rodriguez-Chiaradia DA, Alcalde M, Elias T, Jara-Palomares L, Rivas A, Alonso A, Garcia-Ortega A, Sancho T, Morillo R, Garcia-Bragado F, Hernandez-Blasco L, Uresandi F, Madridano O, Aguero R, Monreal M; OSIRIS Investigators. Feasibility of a screening algorithm for chronic thromboembolic pulmonary hypertension: The OSIRIS study. Thromb Res. 2023 Aug;228:1-9. doi: 10.1016/j.thromres.2023.05.005. Epub 2023 May 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remedios Otero Candelera study chair
Hospital Universitario Virgen del Rocío IBIS
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Pulmonary Thromboembolisms, run by Sociedad Española de Neumología y Cirugía Torácica at 23 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary hypertension (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03134898, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.