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Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

NCT05825417 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-03

No results posted yet for this study

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

Conditions

Interventions

DRUG

Selexipag

If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary.

DRUG

Riociguat

If Arm A - Up-titration to maximum tolerated dose followed by de-escalation If Arm B - Up-titration to maximum tolerated dose followed by observation, modification or transition at discretion of responsible care team where necessary.

DEVICE

CardioMEMS pulmonary artery pressure monitor

Implantation and remote monitoring established with patient initiated daily readings

DEVICE

Confirm Rx

Implantation and remote monitoring established with automated daily readings / downloads

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • University of Sheffield

    collaborator OTHER

  • University of Newcastle Upon-Tyne

    collaborator OTHER

  • University of Cambridge

    collaborator OTHER

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alexander Rothman, MD / PhD · University of Sheffield

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-14
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825417 on ClinicalTrials.gov