RecruitingPHASE4INTERVENTIONAL

Pulmonary Hypertension: Intensification and Personalisation of Combination Rx

This study focuses on improving treatment for Pulmonary Arterial Hypertension (PAH), a condition affecting the blood vessels in the lungs. Doctors want to see if small, implanted devices can help them quickly figure out if a patient’s medication is working well. The study uses approved medications, Selexipag and Riociguat, and two types of implanted monitors: one for lung pressure (CardioMEMS) and another to track activity (Confirm Rx). The main goal is to find out if changes to a patient's treatment plan can be detected early using these devices, which could lead to more personalised and effective care for individuals with PAH.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

14 Jun 2023

Estimated completion

01 Jan 2026

Pulmonary Arterial Hypertension

What is this study about?

This research study is all about finding better and more personal ways to treat a serious lung condition called Pulmonary Arterial Hypertension (PAH). In PAH, the blood vessels in your lungs become narrow, making it harder for your heart to pump blood, which can lead to breathlessness and tiredness. We know that different people react differently to medicines, so a treatment that works well for one person might not be the best for another.

Currently, it can take a while to know if a particular medicine is truly working. This study hopes to speed up that process by using small, implanted devices. These devices can constantly monitor important information, like the pressure in your lungs or your daily activity levels. The idea is that if doctors can see changes quickly after adjusting your medication, they can tailor your treatment plan much faster and more effectively to your specific needs. This could mean you get the right medicine, at the right dose, sooner.

The study will involve trying out two approved medications, Selexipag and Riociguat, in a structured way. By comparing how your body responds to these different treatments, and by using the information from the implanted devices, the researchers hope to gather enough evidence to show that this personalised approach can really make a difference. Ultimately, this could lead to more precise and individualised care for people living with PAH, helping them to feel better and improve their quality of life.

Key takeaways

Aims to find better, more personal ways to treat Pulmonary Arterial Hypertension (PAH).
Uses small implanted devices to monitor lung pressure and activity.
Compares two approved medications (Selexipag & Riociguat) to see how they affect individuals.
Hopes to allow doctors to tailor PAH treatment more quickly and effectively.
Could help lead to more precise, evidence-based care for PAH patients.
You can stop participating at any time without it affecting your regular care.

Who may be eligible?

To join this study, you would generally need to be between 18 and 80 years old and have a specific type of Pulmonary Arterial Hypertension (PAH) that is either inherited, caused by certain drugs or toxins, or linked to connective tissue disease. You should already be on a stable treatment for your PAH, using a combination of an ERA and a PDE5i medication, for at least a month, unless you couldn't tolerate those treatments. You also need to be able to walk a certain distance (more than 50 metres) in six minutes at the start of the study, and your kidney function should be good.

There are also some reasons why you wouldn't be able to join. For example, if you are pregnant, or if your PAH is due to other specific conditions like HIV, liver problems, or certain heart or lung diseases. You also can't participate if you've had an unprovoked blood clot in your lungs, have an active infection, or allergies to the study medications (Selexipag or Riociguat). Severe kidney problems, anaemia (low blood iron), or significant heart problems other than your PAH would also prevent you from joining.

Additionally, you must be able to understand the study and agree to take part. The research team will carefully check all these requirements to make sure the study is safe and suitable for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Do you have PAH that is idiopathic, inherited, or linked to drugs/connective tissue disease?
Are you currently on stable PAH medication (ERA and PDE5i) for at least a month, or couldn't tolerate them?
Are you able to walk more than 50 metres in a 6-minute walk test?
Are you NOT pregnant and don't have other specific serious health conditions like severe kidney disease or certain heart problems?
Can you understand the study information and agree to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have tiny, approved medical devices implanted. One device, called CardioMEMS, will help monitor the pressure in your lungs, and another, Confirm Rx, will track your activity. After that, you'll take part in a study involving two approved medications, Selexipag and Riociguat. You'll take these medications in a specific order, trying one for a period, then switching to the other, to see how your body responds.

Throughout the study, you'll have regular check-ups, which will involve standard tests to look at your physiology, activity levels, and how your quality of life is affected. The information from your implanted devices will be monitored remotely, meaning doctors can see readings from your home. The total duration of the study would involve several visits for assessments and device checks, along with the periods of taking the study medicines. The team will be able to tell you exactly how long your involvement would be.

Potential risks and benefits

Taking part in this study could potentially offer you several benefits. You would receive close and personalised monitoring of your condition, and doctors might be able to tailor your treatment more effectively and quickly than with standard care. This could lead to better management of your PAH symptoms and an improved quality of life. However, like all medical studies, there are potential risks. These include the usual risks associated with having small devices implanted, such as infection or discomfort, as well as potential side effects from the study medications. You will be fully informed of all known risks before you decide to participate, and importantly, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Sheffield Teaching Hospitals NHS FT
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a serious condition where the blood vessels in your lungs become narrowed, making it hard for your heart to pump blood. This can cause shortness of breath and tiredness.

What are the implanted devices used for?

The devices, CardioMEMS and Confirm Rx, are tiny monitors. CardioMEMS checks the pressure in your lungs, and Confirm Rx tracks your activity. They help doctors quickly see how your body responds to changes in medication.

Will I have to take new medications?

The study uses two approved medications, Selexipag and Riociguat. You'll try each one in a planned sequence to help researchers understand which works best and how the devices can track this.

How long will the study last?

The exact total duration will be explained by the study team, as it involves several periods of medication and assessments, but it will involve careful monitoring over a period of time.

Can I stop participating if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and this will not affect the usual medical care you receive.

How to find out more

Jennifer Dick, PhD

jennifer.dick@sheffield.ac.uk +44 (0) 114 2159550 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.