check_circleStudy Completed
Pulmonary Arterial Hypertension
Bayer Identifier:
20267
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
104Trial Dates
July 2019 - May 2020Phase
Phase 4Could I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many facilities | Many locations, Argentina |
Primary Outcome
- Age at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Sexdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Ethnicitydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Descriptive analysis of comorbidities at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- PAH-subgroup at baseline as assessed by physicianPAH-subgroups may be idiopathic, heritable, drug- or toxin-induced, or associated PAH (with CTD or HIV or portopulmonary hypertension or repaired congenital heart disease).date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Right atrial pressure at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery pressure at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary vascular resistance at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Cardiac Index (CI) at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary vasoreactivity at baseline by pulmonary artery pressureYes / No - variabledate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Peak oxygen consumption by cardiopulmonary exercise test at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Right atrial area at baseline by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pericardial effusion at baseline by echocardiographyPatients may have no, mild, moderate or severe pericardial effusion.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Right ventricular function at baseline by echocardiographyPatients may have a normal, mild, moderate and severe right ventricular function.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery systolic pressure at baseline by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Left ventricular ejection fraction at baseline by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- 6-minute walking distance at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary hypertension functional class according to WHO classification at baselineFour functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Time from onset of diagnostic symptoms to PAH-diagnosisdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Symptoms progression at baseline assessed by physicianPatient may display no, a slow or rapid progression of symptoms.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Syncope frequency at baselineNo, occasional or repeated syncopedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Systolic blood pressure at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Heart rate at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Body weight at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Body height at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Body mass index at baselinedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Concentration of diagnostic markers for heart failure in blood at baselineUsed diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Drug class of supportive PAH treatmentSupportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Drug class of PAH-treatment after diagnosisPAH-treatments are assigned to six drug classes: endothelin receptor antagonists (ERA), PDE5 inhibitors, prostanoides, prostacyclin receptor agonists, soluble guanylate cyclase (sGC) stimulants and calcium blockers.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- PAH risk status at baseline according to ESC/ERS 2015 guidelinesPatients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Overall survival ratedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Time from diagnosis to death from any causedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Outcome
- Right atrial pressure at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery pressure at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Cardiac Index (CI) at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamicsdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Peak oxygen consumption by cardiopulmonary exercise test at follow-update_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Right atrial area at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pericardial effusion at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Right ventricular function at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary artery systolic pressure at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Left ventricular ejection fraction at follow-up by echocardiographydate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- 6-minute walking distance at follow-update_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary hypertension functional class according to WHO classification at baselineFour functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Symptoms progression at follow-update_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Syncope frequency at follow-update_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Concentration of diagnostic markers for heart failure in blood at follow-upUsed diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- PAH risk status at follow-up according to ESC/ERS 2015 guidelinesPatients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Cause of deathdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Time from diagnosis to death from any causedate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Pulmonary transplantYes or Nodate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Time from diagnosis to pulmonary transplantdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Time from diagnosis to first hospitalization due to PAH-progressiondate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Number of hospitalizations per year due to PAH-progressiondate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Proportion of patients with low PAH riskRisk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Proportion of patients with intermediate+high PAH riskRisk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Survival rate of patients with low risk for PAHdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Survival rate of patients with intermediate or high risk for PAHdate_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- PAH risk status of patients without transplant being alive at the date of latest medical records according to ESC/ERS 2015 guidelinesPatients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.date_rangeTime Frame:Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A