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NCT05825417Not yet recruiting

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

A Multicentre Randomised Cross-over Trial of Disease Specific Therapy in Patients With Pulmonary Arterial Hypertension (PAH) Implanted With Pulmonary Artery Pressure and Cardiac Rhythm Monitoring Devices (CardioMEMS/ConfirmRx)
Sheffield Teaching Hospitals NHS Foundation TrustPhase 4ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Pulmonary Arterial Hypertension
Drug/Device/Intervention
Selexipag
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Timeline & enrollment
Phase
Phase 4
Start date
Apr 01, 2023
End date
Jan 01, 2026
Enrollment
40 participants
Primary outcome

Right Ventricular Stroke Volume (RVSV) flow on each therapy measured by MRI RSVS (flow) on each therapy measured by MRI

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

ICD-10 classifications
Primary pulmonary hypertensionOther secondary pulmonary hypertensionPulmonary heart disease and diseases of pulmonary circulationStenosis of pulmonary arteryPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05825417
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05825417 through Pure Global AI's free database. This Phase 4 trial is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and is currently Not yet recruiting. The study focuses on Pulmonary Arterial Hypertension. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.