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
- Registration Number
- NCT03863990
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
The primary objective of the study is to describe baseline clinical characteristics and overall survival in a cohort of patients with pulmonary arterial hypertension (PAH) of WHO functional class I in Argentina.
Secondary objectives are to study the discriminatory ability of the risk assessment tool presented in the European Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines and to explore the potential prognostic advantage of a low-risk profile at follow-up as treatment goal.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
- 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.
- 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 (PVOD) or Pulmonary Capillary Haemangiomatosis (PCH).
- Hypertrophic obstructive cardiomyopathy.
- Severe proven or suspected coronary artery disease.
- Congenital or acquired valvular or myocardial disease if clinically significant apart from tricuspid valvular insufficiency due to pulmonary hypertension.
- Underlying medical disorders at baseline with an anticipated life expectancy below 2 years (e.g. active cancer disease with localized and/or metastasized tumor mass) or Clinical relevant hepatic dysfunction (Child-Pugh B and C) or Renal insufficiency (glomerular filtration rate <30 mL/min).
- Diagnosis of a pulmonary hypertension from WHO groups 2, 3, 4 or 5.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with PAH PAH medication Adult male and female patients from Argentina diagnosed with pulmonary arterial hypertension (PAH) of WHO functional class I between 01-Jan-2012 and 31-Dec-2017 and with at least one year of follow-up.
- Primary Outcome Measures
Name Time Method Sex Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Age at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Ethnicity Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Descriptive analysis of comorbidities at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Overall survival rate Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 PAH-subgroup at baseline as assessed by physician Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 PAH-subgroups may be idiopathic, heritable, drug- or toxin-induced, or associated PAH (with CTD or HIV or portopulmonary hypertension or repaired congenital heart disease).
Right atrial pressure at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary artery pressure at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Cardiac Index (CI) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pericardial effusion at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patients may have no, mild, moderate or severe pericardial effusion.
Right ventricular function at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patients may have a normal, mild, moderate and severe right ventricular function.
6-minute walking distance at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Right atrial area at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary artery systolic pressure at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Left ventricular ejection fraction at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary hypertension functional class according to WHO classification at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Syncope frequency at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 No, occasional or repeated syncope
Systolic blood pressure at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Heart rate at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Body weight at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary vasoreactivity at baseline by pulmonary artery pressure Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Yes / No - variable
Peak oxygen consumption by cardiopulmonary exercise test at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Time from onset of diagnostic symptoms to PAH-diagnosis Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Body mass index at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Concentration of diagnostic markers for heart failure in blood at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Drug class of supportive PAH treatment Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
Symptoms progression at baseline assessed by physician Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patient may display no, a slow or rapid progression of symptoms.
Drug class of PAH-treatment after diagnosis Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 PAH-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.
PAH risk status at baseline according to ESC/ERS 2015 guidelines Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Body height at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Time from diagnosis to death from any cause Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
- Secondary Outcome Measures
Name Time Method Survival rate of patients with low risk for PAH Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary artery wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Right atrial pressure at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Right ventricular function at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Left ventricular ejection fraction at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Cause of death Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Time from diagnosis to death from any cause Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Survival rate of patients with intermediate or high risk for PAH 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 guidelines Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Right atrial area at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pericardial effusion at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Peak oxygen consumption by cardiopulmonary exercise test at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Pulmonary hypertension functional class according to WHO classification at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Symptoms progression at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Syncope frequency at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 PAH risk status at follow-up according to ESC/ERS 2015 guidelines Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Time from diagnosis to pulmonary transplant Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Number of hospitalizations per year due to PAH-progression Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Concentration of diagnostic markers for heart failure in blood at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Pulmonary transplant Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Yes or No
Proportion of patients with low PAH risk Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Pulmonary artery systolic pressure at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 6-minute walking distance at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Proportion of patients with intermediate+high PAH risk Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018 Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Time from diagnosis to first hospitalization due to PAH-progression Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Trial Locations
- Locations (1)
Many facilities
🇦🇷Multiple Locations, Argentina