Health TrialsbyHealthPanel

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

ConditionPulmonary Arterial Hypertension
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Selexipag

    Drug

    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.

  • Riociguat

    Drug

    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.

  • CardioMEMS pulmonary artery pressure monitor

    Device

    Implantation and remote monitoring established with patient initiated daily readings

  • Confirm Rx

    Device

    Implantation and remote monitoring established with automated daily readings / downloads

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Arm A (selexipag/riociguat)Active comparator 4 interventions
Group B: Arm B (riociguat/selexipag)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

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

This provides a robust, objective assessment of clinical efficacy which, if met, will mean that a change in therapy has provided a clinically meaningful change in physiology

Time frame
Baseline to Week 12

Secondary outcomes

1

Haemodynamics - Total Pulmonary Resistance (TPR)

Change in TPR (Woods Units) on each therapy to determine clinical efficacy

Time frame
From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
2

Haemodynamics - mean Pulmonary Artery Pressure (mPAP)

Change in mPAP (mmHg) on each therapy to determine clinical efficacy

Time frame
From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
3

Haemodynamics - Cardiac Output (CO)

Change in CO (L/min) on each therapy to determine clinical efficacy

Time frame
From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks
4

Haemodynamics - Cardiac Index

Change in cardiac index (L/min/m\^2) on each therapy to determine clinical efficacy

Time frame
From baseline and area under the curve to 4 weeks, 8 weeks and 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
Apply now