Feasibility of Novel Clinical Trial Infrastructure, Design and Technology for Early Phase Studies in Patients With Pulmonary Hypertension (FIT-PH)
This study is exploring a new approach to help people with pulmonary hypertension, a condition where there's high blood pressure in the arteries leading to your lungs. It's an 'observational' study, meaning researchers will carefully watch and gather information, but won't be giving new treatments. The main idea is to see how well small sensors, placed in the body to measure lung artery pressure, work alongside fitness trackers worn on the wrist. Doctors want to find out if using these tools is safe and practical. They hope this information can lead to better care, helping them decide on the best medication doses, improve quality of life, and better predict how the condition might develop for patients.
At a glance
What is this study about?
This study, called FIT-PH, is all about finding better ways to look after people with pulmonary hypertension. This is a serious condition where the blood pressure in the arteries that go from your heart to your lungs becomes too high.
The researchers want to see if using some clever new technology can help. This includes tiny sensors that are placed inside your body to measure the pressure in your lung arteries, and also wearable devices, like a fitness tracker, to monitor your daily activity. By using both of these, the study aims to understand if these tools can give doctors a clearer picture of your health and how your condition is progressing.
Ultimately, the goal is to make sure these new monitoring methods are safe and easy to use. The information gathered could help doctors make more informed decisions about your treatment, including adjusting medications, improving your quality of life, and getting a better idea of what might happen in the future. It's hoped this could lead to more personalised and effective care for people living with pulmonary hypertension.
Key takeaways
- This study explores new ways to monitor pulmonary hypertension using smart technology.
- It's an observational study, focusing on gathering information rather than new treatments.
- Small internal sensors and wearable activity trackers will be used.
- The aim is to see if better monitoring can improve patient care and understanding of the condition.
- Participation involves medical checks, questionnaires, and a minor procedure for sensor placement.
- You can withdraw from the study at any time without affecting your usual care.
Who may be eligible?
To join this study, you would need to be an adult, aged 18 or over, and have a confirmed diagnosis of pulmonary hypertension. Your kidneys also need to be working reasonably well, and your body mass index (BMI) should generally be below 35.
There are some reasons why you might not be able to take part. For example, if you have a current infection, or if you've recently had a major heart or blood vessel problem. Also, if you have certain existing heart devices or blood clotting issues, you might not be suitable.
If you're a woman who could become pregnant, you'd need to have a negative pregnancy test. You also need to be able to understand and agree to take part, and be willing to follow the study rules.
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 18 years old or older?
- Do you have a diagnosis of pulmonary hypertension?
- Is your kidney function generally healthy?
- Do you have a Body Mass Index (BMI) of less than 35?
- Are you able and willing to follow study instructions?
What does participation involve?
If you're interested and seem suitable, a member of the research team will explain the study in detail, either face-to-face or over the phone. If you're happy to move forward, you'll get an information sheet to read.
Next, you'd have a screening visit. If you meet all the requirements, you'll officially agree to take part by signing a consent form. We'd then review your medical history, current medications, allergies, and any hospital stays in the last year. You'd have a physical check-up, including measurements like blood pressure and heart rate, and perform a six-minute walk test. You'd also complete a questionnaire about your quality of life, have an ECG (heart tracing), and some blood tests. We'll also look at recent scans you might have had, like heart ultrasounds.
If all looks good, you would then have a small procedure to have the lung artery pressure sensor implanted. If you take certain blood thinners, you might need to stop them for a couple of days before this procedure, and your doctor would advise you if you need a different blood thinner for a short time.
Potential risks and benefits
Locations (1)
- Sheffield Teaching Hospitals NHS Foundation TrustVerified postcodeSheffield, United Kingdom· Recruiting
Common questions
What is pulmonary hypertension?
It's a serious condition where the blood pressure in the arteries that carry blood from your heart to your lungs is too high.
What is an 'observational' study?
It means doctors will watch closely and collect information about your health and how new monitoring tools work, without giving you new or experimental treatments.
Will I have to take new medicine?
No, this study isn't about new medications. It's about using new monitoring devices to help manage your existing treatment better.
What are the new monitoring tools mentioned?
They include a small sensor that measures pressure in your lung arteries and a wearable activity tracker, like a fitness watch.
Can I leave the study at any time?
Yes, you are free to leave the study at any point without it affecting your normal medical care.
How to find out more
Alexander Rotherman
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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