Pulmonary Hypertension Real World Data Analysis
Research type
Research Study
Full title
Pulmonary Hypertension (PH) population characterisation and epidemiological analysis
IRAS ID
269963
Contact name
David Kiely
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Pulmonary Arterial Hypertension (PAH), is a progressive and rare disease caused by constriction of the pulmonary arteries. There are other types of Pulmonary Hypertension, including Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Sarcoidosis-Associated Pulmonary Hypertension (SAPH). Due to the complexity, late diagnosis and absence of real-world studies there is currently a lack of understanding regarding the clinical pathway leading to diagnosis and post-diagnosis. There is also the need to further explore and study patient related outcomes associates with these diseases in routine clinical practice. IQVIA has been commissioned by Actelion to carry out a retrospective real world data analysis of UK PAH, CTEPH and SAPH patients. The study will focus on describing and comparing these populations in terms of characteristics of patients, clinical pathways pre-diagnosis, treatment patterns post diagnosis, clinical outcomes and Healthcare Resource Utilisation. There is great opportunity for both Actelion and the broader scientific/research community to improve the body of knowledge around these three sub-types and further enhance the possibility of developing better clinical pathways, improving treatment patterns and informing clinical guidelines to improve patient’s health and Quality of Life.
The study design is a non-interventional retrospective database analysis of a PH (including its subtypes; PAH, CTEPH and SAPH) patient cohort based on data from the Pulmonary Vascular Disease Unit at Sheffield Teaching Hospitals NHS Foundation Trust (STHFT) and HES data from NHS Digital.
This research will be conducted as a collaboration between the STHFT, University of Sheffield (UoS), IQVIA and Actelion. The study is expected to be completed within ~15 months, pending research governance and regulatory approvals. The project will be executed by IQVIA and overseen by an analytical committee comprising leading academics in pulmonary hypertension research, and industry employees. Ethics and research governance arrangements will be addressed by suitable approvals and will be guided by STHFT.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0331
Date of REC Opinion
2 Dec 2019
REC opinion
Further Information Favourable Opinion