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 range

18 Years

Sex

ALL

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

18 Years

Sex

ALL

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