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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)

29 de abril de 2021 atualizado por: Bayer

Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)

In this study researchers want to learn more about Pulmonary Arterial Hypertension, a type of high blood pressure in the lungs related to the narrowing of the small blood vessels in the lungs (group 1 according to WHO classification). Goal of the study is to describe the signs and risk factors of the illness at study start and the chances of survival.

Visão geral do estudo

Status

Concluído

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

Observacional

Inscrição (Real)

104

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Multiple Locations, Argentina
        • Many facilities

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

Adults patients with pulmonary arterial hypertension from tertiary care centers in Argentina

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

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Any PAH-targeted medication

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Age at baseline
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
Sex
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
Ethnicity
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
Descriptive analysis of comorbidities at baseline
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
PAH-subgroup at baseline as assessed by physician
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-subgroups may be idiopathic, heritable, drug- or toxin-induced, or associated PAH (with CTD or HIV or portopulmonary hypertension or repaired congenital heart disease).
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right atrial pressure 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
Pulmonary artery pressure 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
Pulmonary vascular resistance 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
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
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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
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
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Pulmonary vasoreactivity at baseline by pulmonary artery pressure
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Yes / No - variable
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Peak oxygen consumption by cardiopulmonary exercise test at baseline
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 atrial area at baseline 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
Pericardial effusion at baseline by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have no, mild, moderate or severe pericardial effusion.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Right ventricular function at baseline by echocardiography
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have a normal, mild, moderate and severe right ventricular function.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Tricuspid annular plane systolic excursion (TAPSE) at baseline 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 baseline 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 baseline 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
6-minute walking distance at baseline
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 hypertension functional class according to WHO classification at baseline
Prazo: 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
Time from onset of diagnostic symptoms to PAH-diagnosis
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
Symptoms progression at baseline assessed by physician
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patient may display no, a slow or rapid progression of symptoms.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Syncope frequency at baseline
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
No, occasional or repeated syncope
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Systolic blood pressure at baseline
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
Heart rate at baseline
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
Body weight at baseline
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
Body height at baseline
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
Body mass index at baseline
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 baseline
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
Drug class of supportive PAH treatment
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Drug class of PAH-treatment after diagnosis
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH-treatments are assigned to six drug classes: endothelin receptor antagonists (ERA), PDE5 inhibitors, prostanoides, prostacyclin receptor agonists, soluble guanylate cyclase (sGC) stimulants and calcium blockers.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
PAH risk status at baseline according to ESC/ERS 2015 guidelines
Prazo: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Overall survival rate
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
Time from diagnosis to death from any cause
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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pulmonary hypertension functional class according to WHO classification at baseline
Prazo: 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
Time from diagnosis to death from any cause
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 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
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
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
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
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
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
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
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
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
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
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
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
Time from diagnosis to pulmonary transplant
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
Time from diagnosis to first hospitalization due to PAH-progression
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
Number of hospitalizations per year due to PAH-progression
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
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.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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.
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Survival rate of patients with low 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
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
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
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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de julho de 2019

Conclusão Primária (Real)

11 de maio de 2020

Conclusão do estudo (Real)

11 de maio de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

19 de fevereiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de março de 2019

Primeira postagem (Real)

5 de março de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de maio de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de abril de 2021

Última verificação

1 de abril de 2021

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

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Informações sobre medicamentos e dispositivos, documentos de estudo

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Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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