Pulmonary Arterial HypertensionSTARTNCT03863990
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
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in Argentina.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- PAH medication
- How many people
- 104 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Jul 2019to 11 May 2020
- 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: Adults patients with pulmonary arterial hypertension from tertiary care centers in Argentina
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
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.
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- PAH medication
- Keywords
- PAH prognosis, PAH outcomes, PAH survival, PAH risk status
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAH medicationDrug
Any PAH-targeted medication
| Study group | Role | What they receive |
|---|---|---|
| Patients with PAH | 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. Receives: Drug: PAH medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Sex
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Ethnicity
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Descriptive analysis of comorbidities at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-subgroup at baseline as assessed by physician
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).
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial pressure at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vasoreactivity at baseline by pulmonary artery pressure
Yes / No - variable
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at baseline by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at baseline by echocardiography
Patients may have no, mild, moderate or severe pericardial effusion.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at baseline by echocardiography
Patients may have a normal, mild, moderate and severe right ventricular function.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at baseline by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at baseline by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary hypertension functional class according to WHO classification at baseline
Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from onset of diagnostic symptoms to PAH-diagnosis
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at baseline assessed by physician
Patient may display no, a slow or rapid progression of symptoms.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at baseline
No, occasional or repeated syncope
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Systolic blood pressure at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Heart rate at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body weight at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body height at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body mass index at baseline
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at baseline
Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Drug class of supportive PAH treatment
Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Drug class of PAH-treatment after diagnosis
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.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at baseline according to ESC/ERS 2015 guidelines
Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Overall survival rate
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary outcomes (30)
Right atrial pressure at follow-up by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics
Measured: 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
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
Measured: 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
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at follow-up
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at follow-up by echocardiography
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at follow-up
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary hypertension functional class according to WHO classification at baseline
Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at follow-up
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at follow-up
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at follow-up
Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at follow-up according to ESC/ERS 2015 guidelines
Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cause of death
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary transplant
Yes or No
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to pulmonary transplant
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to first hospitalization due to PAH-progression
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Number of hospitalizations per year due to PAH-progression
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with low PAH risk
Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with intermediate+high PAH risk
Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with low risk for PAH
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with intermediate or high risk for PAH
Measured: 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
Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Measured: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Jul 2019
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863990
- Sponsor's protocol ID
- 20267
- Acronym
- START
- Status last verified
- Apr 2021
- First submitted
- 19 Feb 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
- ClinicalTrials.gov ID
- NCT03863990
- Acronym / sponsor ID
- START / 20267
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- PAH prognosis, PAH outcomes, PAH survival, PAH risk status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 5 Mar 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PAH | – | Drug: PAH medicationAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with pulmonary arterial hypertension from tertiary care centers in Argentina
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAH medicationAny PAH-targeted medication | Drug | Patients with PAH |
Primary outcome
Age at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Sex
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Ethnicity
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Descriptive analysis of comorbidities at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-subgroup at baseline as assessed by physician
Time frame: 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
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at baseline by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at baseline by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vasoreactivity at baseline by pulmonary artery pressure
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Yes / No - variable
Peak oxygen consumption by cardiopulmonary exercise test at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at baseline by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at baseline by echocardiography
Time frame: 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
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have a normal, mild, moderate and severe right ventricular function.
Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at baseline by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at baseline by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary hypertension functional class according to WHO classification at baseline
Time frame: 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).
Time from onset of diagnostic symptoms to PAH-diagnosis
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at baseline assessed by physician
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patient may display no, a slow or rapid progression of symptoms.
Syncope frequency at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
No, occasional or repeated syncope
Systolic blood pressure at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Heart rate at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body weight at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body height at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Body mass index at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at baseline
Time frame: 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
Time frame: 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.
Drug class of PAH-treatment after diagnosis
Time frame: 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
Time frame: 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.
Overall survival rate
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
30 secondary outcomes
Right atrial pressure at follow-up by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics
Time 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 hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
Time 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 hemodynamics
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at follow-up
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial area at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pericardial effusion at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary artery systolic pressure at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Left ventricular ejection fraction at follow-up by echocardiography
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
6-minute walking distance at follow-up
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary hypertension functional class according to WHO classification at baseline
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Symptoms progression at follow-up
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at follow-up
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Concentration of diagnostic markers for heart failure in blood at follow-up
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at follow-up according to ESC/ERS 2015 guidelines
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Cause of death
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to death from any cause
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary transplant
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to pulmonary transplant
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Time from diagnosis to first hospitalization due to PAH-progression
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Number of hospitalizations per year due to PAH-progression
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with low PAH risk
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Proportion of patients with intermediate+high PAH risk
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with low risk for PAH
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with intermediate or high risk for PAH
Time 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 guidelines
Time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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 4 May 2021.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension, run by Bayer at 1 site in Argentina.
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 3 inclusion and 8 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. 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?
Age at baseline (time frame: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 May 2021.