check_circleStudy Completed

Pulmonary Arterial Hypertension

Bayer Identifier:

20267

ClinicalTrials.gov Identifier:

NCT03863990

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
104
Trial Dates
July 2019 - May 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many facilitiesMany locations, Argentina

Primary Outcome

  • Age at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Sex
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Ethnicity
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Descriptive analysis of comorbidities at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • PAH-subgroup at baseline as assessed by physician
    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).
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Right atrial pressure at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary artery pressure at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Cardiac Index (CI) at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary vasoreactivity at baseline by pulmonary artery pressure
    Yes / No - variable
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Peak oxygen consumption by cardiopulmonary exercise test at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Right atrial area at baseline by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pericardial effusion at baseline by echocardiography
    Patients may have no, mild, moderate or severe pericardial effusion.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Right ventricular function at baseline by echocardiography
    Patients may have a normal, mild, moderate and severe right ventricular function.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary artery systolic pressure at baseline by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Left ventricular ejection fraction at baseline by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • 6-minute walking distance at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary hypertension functional class according to WHO classification at baseline
    Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Time from onset of diagnostic symptoms to PAH-diagnosis
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Symptoms progression at baseline assessed by physician
    Patient may display no, a slow or rapid progression of symptoms.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Syncope frequency at baseline
    No, occasional or repeated syncope
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Systolic blood pressure at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Heart rate at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Body weight at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Body height at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Body mass index at baseline
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Concentration of diagnostic markers for heart failure in blood at baseline
    Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Drug class of supportive PAH treatment
    Supportive treatments for PAH are assigned to four drug classes: diuretics, anticoagulants, oxygen and other.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Drug class of PAH-treatment after diagnosis
    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.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • PAH risk status at baseline according to ESC/ERS 2015 guidelines
    Patients may have a low, intermediate or high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Overall survival rate
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Time from diagnosis to death from any cause
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Secondary Outcome

  • Right atrial pressure at follow-up by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics
    date_rangeTime Frame:
    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
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Peak oxygen consumption by cardiopulmonary exercise test at follow-up
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Right atrial area at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pericardial effusion at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Right ventricular function at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary artery systolic pressure at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Left ventricular ejection fraction at follow-up by echocardiography
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • 6-minute walking distance at follow-up
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary hypertension functional class according to WHO classification at baseline
    Four functional classes ranging from Class I (Pulmonary hypertension without limited physical activity) to Class IV (Pulmonary hypertension with strongly limited physical activity).
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Symptoms progression at follow-up
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Syncope frequency at follow-up
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Concentration of diagnostic markers for heart failure in blood at follow-up
    Used diagnostic marker are either Brain natriuretic Peptide (BNP) or N-terminal pro b-type Natriuretic Peptide (NT-proBNP).
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • PAH risk status at follow-up according to ESC/ERS 2015 guidelines
    Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Cause of death
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Time from diagnosis to death from any cause
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Pulmonary transplant
    Yes or No
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Time from diagnosis to pulmonary transplant
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Time from diagnosis to first hospitalization due to PAH-progression
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Number of hospitalizations per year due to PAH-progression
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Proportion of patients with low PAH risk
    Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Proportion of patients with intermediate+high PAH risk
    Risk status is assessed according to the Society of Cardiology and European Respiratory Society (ESC/ERS) 2015 guidelines.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Survival rate of patients with low risk for PAH
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
  • Survival rate of patients with intermediate or high risk for PAH
    date_rangeTime Frame:
    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
    Patients may have low, intermediate and high risk for PAH according to the European Society of Cardiology and European Respiratory Society 2015 guidelines.
    date_rangeTime Frame:
    Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Trial design

Survival and Prognostic Factors in Pulmonary Arterial Hypertension. A Multicenter Observational Registry (START)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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