- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Multiple Locations, Argentinië
- Many facilities
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Age at baseline
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pulmonary hypertension functional class according to WHO classification at baseline
Tijdsspanne: 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).
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to death from any cause
Tijdsspanne: 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 atrial pressure at follow-up by right heart catheterization hemodynamics
Tijdsspanne: 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
Tijdsspanne: 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 vascular resistance at follow-up by right heart catheterization hemodynamics
Tijdsspanne: 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 wedge pressure (PAWP) at follow-up by right heart catheterization hemodynamics
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Peak oxygen consumption by cardiopulmonary exercise test at follow-up
Tijdsspanne: 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 atrial area at follow-up by echocardiography
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Pericardial effusion at follow-up by echocardiography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
6-minute walking distance at follow-up
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Symptoms progression at follow-up
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Cause of death
Tijdsspanne: 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 transplant
Tijdsspanne: 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
|
Time from diagnosis to pulmonary transplant
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Time from diagnosis to first hospitalization due to PAH-progression
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Number of hospitalizations per year due to PAH-progression
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
|
Proportion of patients with low PAH risk
Tijdsspanne: 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.
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Proportion of patients with intermediate+high PAH risk
Tijdsspanne: 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.
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
Survival rate of patients with low risk for PAH
Tijdsspanne: 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
|
|
Survival rate of patients with intermediate or high risk for PAH
Tijdsspanne: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
|
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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 20267
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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.
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Informatie over medicijnen en apparaten, studiedocumenten
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