CompletedNot Applicable

Study Performed at Various Medical Centers to Learn More About Survival and Expected Course of Pulmonary Arterial Hypertension, a Type of High Blood Pressure in the Lungs Related to the Narrowing of the Small Blood Vessels in the Lungs

Argentina104 participantsStarted 2019-07-15

Plain-language summary

In this study researchers want to learn more about Pulmonary Arterial Hypertension, a type of high blood pressure in the lungs related to the narrowing of the small blood vessels in the lungs (group 1 according to WHO classification). Goal of the study is to describe the signs and risk factors of the illness at study start and the chances of survival.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Consecutive newly diagnosed patients by Right heart catheterization (RHC) from 01-Jan-2012 to 31-Dec-2017, belonging to one of the following of Group 1 PAH subgroups: Idiopathic (IPAH), or Heritable (HPAH), or Drug or toxin induced, or Associated (APAH) with one of the following: Connective tissue disease; Congenital heart disease with simple systemic to pulmonary shunt at least 1 year after surgical repair; Portal Hypertension or HIV infection. * Diagnosis of PAH by RHC exhibiting a mean pulmonary artery pressure (MPAP) ≥ 25 mmHg and a pulmonary artery wedge pressure (PAWP) ≤15 mmHg at normal or reduced cardiac output, according to European Society of Cardiology and European Respiratory Society (ESC/ERS) 2009 guidelines or MPAP ≥ 25 mmHg and a PAWP ≤15 mmHg and a pulmonary vascular resistance (PVR) \> 3 WU according to ESC/ERS 2015 guidelines. * Patients with at least one year documented follow up or that have died or received transplant before 1 year of follow up after baseline RHC and that have initiated treatment with a PAH-targeted medication. Exclusion Criteria: * Patients with severe concomitant left heart disease (left ventricular ejection fraction \<35%). * Patients with restrictive lung disease (Forced vital capacity (FVC) \<60% predicted) other than connective tissue disease or obstructive lung disease (forced expiratory volume (FEV) \<60% predicted, with FEV1/FVC\<70%). * Clinical or radiological evidence of Pulmo-Veno-Occlusive Disease (P…

What they're measuring

Age at baseline

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Sex

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Ethnicity

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Descriptive analysis of comorbidities at baseline

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

PAH-subgroup at baseline as assessed by physician

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Right atrial pressure at baseline by right heart catheterization hemodynamics

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Pulmonary artery pressure at baseline by right heart catheterization hemodynamics

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Trial details

NCT IDNCT03863990

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2020-05-11

View on ClinicalTrials.gov More Pulmonary Arterial Hypertension trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Age at baseline

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Sex

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Ethnicity

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Descriptive analysis of comorbidities at baseline

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

PAH-subgroup at baseline as assessed by physician

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Right atrial pressure at baseline by right heart catheterization hemodynamics

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Pulmonary artery pressure at baseline by right heart catheterization hemodynamics

Timeframe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018