The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.
Study Type
OBSERVATIONAL
Enrollment
110
Ordensklinikum Linz
Linz, Austria
Medical University Vienna
Vienna, Austria
Fakultní Nemocnice Olomouc
Olomouc, Czechia
Všeobecná fakultní nemocnice v Praze
Prague, Czechia
Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris
Paris, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
DRK Kliniken Berlin Westend
Berlin, Germany
University Hospital Carl Gustav Carus of Technical University Dresden
Dresden, Germany
Universitätsmedizin Greifswald
Greifswald, Germany
Gottsegen National Cardiovascular lnstitute
Budapest, Hungary
...and 8 more locations
Time to death or lung transplantation
Time frame: up to year 3
Time to first clinical worsening
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PAH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
Time frame: up to year 3
Total number of clinical worsenings
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
Time frame: up to year 3
Long-term change in 6MWD
6-Minute Walking Distance (6MWD) will be measured in meters
Time frame: up to year 3
Long-term change in PAH treatment regimens
any change or addition of new PH medication including dosing in time
Time frame: up to year 3
Long-term change in risk status
Risk status measured by simplified four-strata risk-assessment tool
Time frame: up to year 3
Long-term change in WHO FC
World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms)
Time frame: up to year 3
Long-term change in BDS
BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum)
Time frame: up to year 3
Long-term change in NT-proBNP/BNP
NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide
Time frame: up to year 3
Long-term change in Pulmonary Vascular Resistance (PVR)
PVR to be measured in WU Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in mean Pulmonary Arterial Pressure (mPAP)
mPAP to be measured in mmHg Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Right Atrial Pressure (RAP)
RAP to be measured in mmHg Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in mean Right Atrial Pressure (mRAP)
mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Cardiac Index (CI)
Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Cardiac Output (CO)
Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Pulmonary capillary wedge pressure (PCWP)
Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Stroke volume index (SVI)
Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in RV-PA coupling
RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in RV end-diastolic area (RVEDA)
RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in RV end-systolic area (RVESA)
RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in RV fractional area change (RVFAC)
RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Right Atrium (RA) area
Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Pericardial effusion
Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine
Time frame: up to year 3
Long-term change in Right ventricular ejection fraction (RVEF)
Parameter will be collected according to clinical routine
Time frame: up to year 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.