- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Multiple Locations, Argentina
- Many facilities
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Age at baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pulmonary hypertension functional class according to WHO classification at baseline
Prazo: 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
Prazo: 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
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
Prazo: 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 vascular resistance at follow-up by right heart catheterization hemodynamics
Prazo: 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 wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamics
Prazo: 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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Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
Prazo: 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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Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamics
Prazo: 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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Peak oxygen consumption by cardiopulmonary exercise test at follow-up
Prazo: 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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Right atrial area at follow-up by echocardiography
Prazo: 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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Pericardial effusion at follow-up by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Right ventricular function at follow-up by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Pulmonary artery systolic pressure at follow-up by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Left ventricular ejection fraction at follow-up by echocardiography
Prazo: 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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6-minute walking distance at follow-up
Prazo: 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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Symptoms progression at follow-up
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Syncope frequency at follow-up
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
|
Concentration of diagnostic markers for heart failure in blood at follow-up
Prazo: 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
Prazo: 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.
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Cause of death
Prazo: 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 transplant
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Yes or No
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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Time from diagnosis to pulmonary transplant
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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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
Prazo: 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.
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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
Prazo: 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
Prazo: 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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PAH risk status of patients without transplant being alive at the date of latest medical records according to ESC/ERS 2015 guidelines
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 20267
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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