Status:
COMPLETED
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
Lead Sponsor:
Bayer
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18+ years
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...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 11 2020
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03863990
Start Date
July 15 2019
End Date
May 11 2020
Last Update
May 4 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Many facilities
Multiple Locations, Argentina