- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03863990
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 (START)
Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
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Multiple Locations, Argentyna
- Many facilities
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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 (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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
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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.
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Any PAH-targeted medication
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Age at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Sex
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Ethnicity
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Descriptive analysis of comorbidities at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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PAH-subgroup at baseline as assessed by physician
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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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).
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Right atrial pressure at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary artery pressure at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Cardiac Index (CI) at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary vasoreactivity at baseline by pulmonary artery pressure
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Yes / No - variable
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Peak oxygen consumption by cardiopulmonary exercise test at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Right atrial area at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pericardial effusion at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patients may have no, mild, moderate or severe pericardial effusion.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Right ventricular function at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patients may have a normal, mild, moderate and severe right ventricular function.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary artery systolic pressure at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Left ventricular ejection fraction at baseline by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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6-minute walking distance at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary hypertension functional class according to WHO classification at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from onset of diagnostic symptoms to PAH-diagnosis
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Symptoms progression at baseline assessed by physician
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patient may display no, a slow or rapid progression of symptoms.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Syncope frequency at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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No, occasional or repeated syncope
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Systolic blood pressure at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Heart rate at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Body weight at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Body height at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Body mass index at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Concentration of diagnostic markers for heart failure in blood at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Drug class of supportive PAH treatment
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Drug class of PAH-treatment after diagnosis
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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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.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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PAH risk status at baseline according to ESC/ERS 2015 guidelines
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Overall survival rate
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to death from any cause
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Pulmonary hypertension functional class according to WHO classification at baseline
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to death from any cause
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Right atrial pressure at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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|
Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary artery wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamics
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Peak oxygen consumption by cardiopulmonary exercise test at follow-up
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Right atrial area at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Pericardial effusion at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Right ventricular function at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Pulmonary artery systolic pressure at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Left ventricular ejection fraction at follow-up by echocardiography
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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6-minute walking distance at follow-up
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Symptoms progression at follow-up
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Syncope frequency at follow-up
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Concentration of diagnostic markers for heart failure in blood at follow-up
Ramy czasowe: 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).
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
PAH risk status at follow-up according to ESC/ERS 2015 guidelines
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Cause of death
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Pulmonary transplant
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Yes or No
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to pulmonary transplant
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to first hospitalization due to PAH-progression
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Number of hospitalizations per year due to PAH-progression
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Proportion of patients with low PAH risk
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Proportion of patients with intermediate+high PAH risk
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Survival rate of patients with low risk for PAH
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Survival rate of patients with intermediate or high risk for PAH
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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PAH risk status of patients without transplant being alive at the date of latest medical records according to ESC/ERS 2015 guidelines
Ramy czasowe: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
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Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 20267
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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