drugset / Trial / NCT05825417
Pulmonary Hypertension: Intensification and Personalisation of Combination Rx
Phase 4
Recruiting
40 enrolled
Sheffield Teaching Hospitals NHS Foundation Trust
University of Cambridge · collabUniversity of Glasgow · collabUniversity of Newcastle Upon-Tyne · collabUniversity of Sheffield · collab
RandomizedCrossoverOpen-labelTreatment
Summary
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
Timeline
- Start
- 2023-06-14
- Primary completion
- 2027-01
- Completion
- 2027-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Riociguat | Other / unclassified | — | — |
| Comparator | Selexipag | Small molecule | — | — |