About this trial
The goal of this clinical trial is to evaluate the capacity of implantable/remote technology for early evaluation of drug therapies in patients with pulmonary arterial hypertension (PAH). The main question it aims to answer is whether structured changes in clinical therapy will be detectable using implanted regulatory approved devices. Participants will will be implanted with approved medical devices and will enter into a study of approved drugs to assess physiology, activity and patient reported quality-of-life (QoL) outcomes. Researchers will compare two therapeutic strategies in each individual patient to see if the study design provides enough evidence to personalise drug treatment plans
Eligibility criteria
Qualifiers
Able to provide informed consent
Age 18-80 years
PAH which is idiopathic, heritable or associated with drugs, toxins or connective tissue disease
Stable PAH therapeutic regime comprising any combination of ERA and PDE5i for at least 1 month prior to screening (unless unable to tolerate therapy)
Disqualifiers
Unable to provide informed consent
Pregnancy
Unprovoked pulmonary embolism (at any time)
Acute infection at time of screening (rescreening is permitted)
Trial design
Treatments tested in this trial
- Selexipag
- Riociguat
- CardioMEMS pulmonary artery pressure monitor
- Confirm Rx
Treatment groups
Sponsors and collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Lead sponsor
University of Glasgow
Collaborator
University of Sheffield
Collaborator
University of Newcastle Upon-Tyne
Collaborator
University of Cambridge
Collaborator