- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Multiple Locations, Argentinien
- Many facilities
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Age at baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 pressure at baseline by right heart catheterization hemodynamics
Zeitfenster: 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 baseline by right heart catheterization hemodynamics
Zeitfenster: 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 baseline by right heart catheterization hemodynamics
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 baseline by echocardiography
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Body weight at baseline
Zeitfenster: 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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Body height at baseline
Zeitfenster: 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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Body mass index at baseline
Zeitfenster: 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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Concentration of diagnostic markers for heart failure in blood at baseline
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Pulmonary hypertension functional class according to WHO classification at baseline
Zeitfenster: 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).
|
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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Time from diagnosis to death from any cause
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Number of hospitalizations per year due to PAH-progression
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Survival rate of patients with intermediate or high risk for PAH
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 20267
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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