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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. april 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

104

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Multiple Locations, Argentina
        • Many facilities

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Age at baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pulmonary hypertension functional class according to WHO classification at baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. juli 2019

Primær fullføring (Faktiske)

11. mai 2020

Studiet fullført (Faktiske)

11. mai 2020

Datoer for studieregistrering

Først innsendt

19. februar 2019

Først innsendt som oppfylte QC-kriteriene

4. mars 2019

Først lagt ut (Faktiske)

5. mars 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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