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

NCT03863990 | Completed

• 1 other identifier: 20267
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Arterial Hypertension

Keywords

PAH prognosis; PAH outcomes; PAH survival; PAH risk status

Outcome Measures

Primary Outcomes (35)

• Age at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Sex

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Ethnicity

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Descriptive analysis of comorbidities at baseline

  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).

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Right atrial pressure at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary artery pressure at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Cardiac Index (CI) at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary vasoreactivity at baseline by pulmonary artery pressure

  Yes / No - variable

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Peak oxygen consumption by cardiopulmonary exercise test at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Right atrial area at baseline by echocardiography

  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.

  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.

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary artery systolic pressure at baseline by echocardiography

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Left ventricular ejection fraction at baseline by echocardiography

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• 6-minute walking distance at baseline

  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).

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Time from onset of diagnostic symptoms to PAH-diagnosis

  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.

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Syncope frequency at baseline

  No, occasional or repeated syncope

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Systolic blood pressure at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Heart rate at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Body weight at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Body height at baseline

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Body mass index at baseline

  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).

  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.

  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.

  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.

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Overall survival rate

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Time from diagnosis to death from any cause

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Secondary Outcomes (30)

• Right atrial pressure at follow-up by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics

  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

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

• Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics

  Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018

Study Arms (1)

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.

Drug: PAH medication

Interventions

PAH medication DRUG

Any PAH-targeted medication

Patients with PAH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many facilities

Multiple Locations, Argentina

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: March 5, 2019
• Study Start: July 15, 2019
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Locations

AR (1)