ClinicaliQ Trial Snapshot
- Pulmonary Hypertension: Intensification and Personalisation of Combination Rx — Recruiting • Phase IV • Cardiology / Cardiovascular • NCT05825417.
- What is being tested: The trial evaluates whether implantable/remote monitoring technology can enable early assessment of drug efficacy and guide treatment intensification decisions in patients with pulmonary arterial hypertension (PAH), moving towards personalised combination therapy approaches.
- Patient eligibility overview: The trial includes patients with diagnosed PAH who are candidates for treatment intensification or combination therapy, with the ability to be monitored via implantable or remote technology devices to track haemodynamic and clinical responses.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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) * WHO functional class III * Resting mPAP ≥20 mmHg, pulmonary capillary wedge pressure ≤15 mmHg, pulmonary vascular resistance ≥2 Wood Units measured by right heart catheterisation at time of diagnosis * 6MWT >50m at entry * Estimated glomerular filtration rate (eGFR)>30 ml/min/1.73 m² at entry (Appendix C) * Inadequate treatment response (clinically determined)
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.