Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSheffield Teaching Hospitals NHS Foundation Trust

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

40 Participants
are divided into 2 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