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NCT03863990 Clinical Trial

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

Pulmonary Arterial Hypertension Clinical Trial

— START  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03863990
Other study ID # 20267
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2019
Est. completion date May 11, 2020

Study information
Verified date April 2021
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date May 11, 2020
Est. primary completion date May 11, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PAH medication
Any PAH-targeted medication

Locations
Country Name City State
Argentina Many facilities Multiple Locations

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Age at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Sex Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Ethnicity Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Descriptive analysis of comorbidities at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 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
Primary Right atrial pressure at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Pulmonary artery pressure at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Pulmonary vascular resistance at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Pulmonary artery wedge pressure (PAWP) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Cardiac Index (CI) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Mixed venous oxygen saturation (SvO2) at baseline by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Pulmonary vasoreactivity at baseline by pulmonary artery pressure Yes / No - variable Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Peak oxygen consumption by cardiopulmonary exercise test at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Right atrial area at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 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
Primary 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
Primary Tricuspid annular plane systolic excursion (TAPSE) at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Pulmonary artery systolic pressure at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Left ventricular ejection fraction at baseline by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 6-minute walking distance at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 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
Primary Time from onset of diagnostic symptoms to PAH-diagnosis Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 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
Primary Syncope frequency at baseline No, occasional or repeated syncope Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Systolic blood pressure at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Heart rate at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Body weight at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Body height at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Body mass index at baseline Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary 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
Primary 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
Primary 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
Primary 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
Primary Overall survival rate Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Primary Time from diagnosis to death from any cause Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Right atrial pressure at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Pulmonary artery pressure at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Pulmonary vascular resistance at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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
Secondary Cardiac Index (CI) at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Mixed venous oxygen saturation (SvO2) at follow-up by right heart catheterization hemodynamics Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Peak oxygen consumption by cardiopulmonary exercise test at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Right atrial area at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Pericardial effusion at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Right ventricular function at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Tricuspid annular plane systolic excursion (TAPSE) at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Pulmonary artery systolic pressure at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Left ventricular ejection fraction at follow-up by echocardiography Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 6-minute walking distance at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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
Secondary Symptoms progression at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Syncope frequency at follow-up Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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). Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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. Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Cause of death Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Time from diagnosis to death from any cause Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Pulmonary transplant Yes or No Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Time from diagnosis to pulmonary transplant Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Time from diagnosis to first hospitalization due to PAH-progression Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Number of hospitalizations per year due to PAH-progression Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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. Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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. Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Survival rate of patients with low risk for PAH Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary Survival rate of patients with intermediate or high risk for PAH Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
Secondary 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. Retrospective analysis of data from 01-Jan-2012 to 31-Dec-2018
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