CompletedPhase IVInterventional

Evaluating the accuracy of remote monitoring technology in capturing how patients respond to treatments for pulmonary arterial hypertension

This study looks at how well treatments for a serious lung condition called Pulmonary Arterial Hypertension (PAH) work. PAH makes it hard for the heart to pump blood, causing breathlessness. Currently, doctors rely on hospital tests, which can be slow and sometimes uncomfortable, to see if treatments are effective. This trial wants to see if small devices, worn at home, can accurately monitor changes in lung pressure and heart activity. This could help doctors quickly understand how a patient responds to different medications, allowing them to personalise treatment better and potentially reduce the need for frequent hospital visits. Participants will try two different approved medications and have devices to monitor their health.

At a glance

Status

Completed

Phase

Phase IV

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

Start

13 Jun 2023

Estimated completion

13 Mar 2026

Pulmonary arterial hypertension (PAH)

What is this study about?

Pulmonary Arterial Hypertension (PAH) is a condition where the small blood vessels in the lungs become narrow and stiff. This makes it harder for your heart to pump blood, leading to symptoms like feeling out of breath and very tired. While there are treatments that can help, doctors currently need to use hospital tests, some of which involve tubes going into the body, to find out if a treatment is working. This can mean it takes a long time to figure out the best medicine for each person.

This study aims to find a new way to check how well PAH treatments are working, using small monitoring devices that are placed inside your body. We want to see if these devices can accurately measure changes in lung pressure and heart function from your home. This could help doctors quickly understand if a particular medicine is right for you, making your treatment more personal and efficient. Ultimately, this approach could reduce the number of hospital visits you need and help you feel better faster.

By taking part, you would be helping us understand if this new way of monitoring can make a real difference for people with PAH. The information we gather will be used to improve how doctors care for patients with this condition in the future.

Key takeaways

The study uses small, implanted devices to monitor PAH treatments.
It aims to find better ways to personalise PAH care and reduce hospital visits.
Participants will try two different approved medications.
Data will be collected from home, alongside hospital visits and questionnaires.
Potential benefits include closer monitoring and helping future patients.
Risks include minor surgery for device implantation and medication side effects.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old, who has been diagnosed with certain types of Pulmonary Arterial Hypertension (PAH). You should already be taking standard PAH medications but still experiencing symptoms, meaning your condition affects your daily activities. You also need to be able to walk a certain distance in a timed walking test.

There are some reasons why you might not be able to join. For example, if you are pregnant, or have other specific heart or lung conditions, you would not be eligible. Also, if you have certain types of PAH, such as those related to HIV or some congenital heart conditions, you wouldn't be able to take part. The research team will carefully check all these details to make sure the study is a good fit for you.

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 aged between 18 and 80?
Do you have a specific type of Pulmonary Arterial Hypertension (PAH)?
Are you currently on PAH medication but still experiencing symptoms?
Can you walk a certain distance during a standard walking test?
Are you *not* pregnant and do you *not* have certain other serious heart or lung conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have two small devices gently placed inside your body. One, called CardioMEMS, is a tiny sensor put into a blood vessel in your lung to measure blood pressure. The other, called ConfirmRx, is a small monitor placed just under the skin on your chest to keep an eye on your heart rate and rhythm. These are minor surgical procedures.

After this, you'll be given two different approved PAH medications, Selexipag and Riociguat, to try at different times during the study. This means you won't just try one, but both, allowing us to see how your body responds to each. The devices will send daily updates about your health to the study team. You'll also come to the hospital for regular check-ups, which will include heart scans (MRI), walking tests, and blood tests. You'll fill out weekly questionnaires about your quality of life and any side effects you might experience. The study is expected to run from June 2023 until January 2027, and you will be part of the monitoring and treatment changes for a period within this timeframe.

Potential risks and benefits

Participants might benefit from very close monitoring of their health, which could help doctors adjust their treatment more quickly. You'll also get the chance to try different approved medications to see which one works best for you. The information gathered will help improve care for many other people with PAH in the future. However, there are some risks. The process of implanting the devices involves minor surgery, which comes with small risks like bruising, pain, or a slight chance of infection or bleeding. The medications themselves can also have side effects, such as headaches, feeling sick, or jaw pain. The study team will watch you very closely for any issues, and you are free to withdraw from the study at any time if you wish.

Locations (8)

Royal Hallamshire Hospital
Approximate
Sheffield, England
Imperial College Healthcare NHS Trust
City only
London, England
Golden Jubilee University National Hospital
City only
Clydebank, Scotland
The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
Royal Brompton Hospital
Approximate
London, England
Royal Free London NHS Foundation Trust
Unverified
London, England
Royal Papworth Hospital NHS Foundation Trust
Unverified
Cambridge, England
Royal United Hospitals Bath NHS Foundation Trust
Unverified
Bath, England

Common questions

What is Pulmonary Arterial Hypertension (PAH)?

PAH is a serious lung condition where the small blood vessels in your lungs become narrow and stiff, making it harder for your heart to pump blood.

What are CardioMEMS and ConfirmRx?

They are small devices implanted into your body. CardioMEMS measures lung pressure, and ConfirmRx monitors your heart rate and rhythm.

What is a 'crossover study'?

It means you will try two different medications (Selexipag and Riociguat) at different times, so we can compare how *your* body responds to each.

Will I have to go to the hospital often?

The devices send daily data from home, but you will still need to attend hospital visits for scans, walking tests, and blood tests.

Who is funding this research?

This study is funded by the Medical Research Council (MRC) in the UK.

How to find out more

Shravya Rao

s.rao@sheffield.ac.uk +44 (0)1142159554 Official trial record

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