RecruitingOBSERVATIONAL

Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial

This study aims to understand how digital sensors can help monitor pulmonary hypertension, a condition affecting the blood vessels in the lungs. Researchers are using small, wearable sensors to measure walking activity in people with this condition. They want to find out if changes in walking patterns, as detected by these sensors, match up with changes in lung pressure, which is measured with a test called a right heart catheterisation. Participants will wear a sensor for one week, three times over several months, to track their movement. The goal is to see if these digital measurements can be a useful way to keep an eye on how well treatments are working and how the condition is progressing.

At a glance

Status

Recruiting

Sponsor

Simon Jäger

Enrolment target

Start

19 Apr 2024

Estimated completion

01 Apr 2027

Pulmonary Hypertension Precapillary Pulmonary Hypertension Right Heart Catheterisation Digital Mobility Outcomes

What is this study about?

This study is looking into a new way to monitor pulmonary hypertension, a condition where the blood pressure in the arteries connecting your heart and lungs is too high. This can make your heart work harder and lead to symptoms like breathlessness. Currently, doctors often use a procedure called a right heart catheterisation to measure these pressures, but it's a more involved test.

The researchers want to see if using a small, wearable sensor – like a fitness tracker but more advanced – can give similar useful information about your condition. This sensor measures your walking activity in your everyday life. If it works well, it could provide a simpler, less invasive way to track your health and how your treatment is working.

By comparing the walking data from the sensors with the pressure readings from the right heart catheterisation, the study hopes to show that these digital measurements are reliable. This could lead to better ways for doctors to understand and manage pulmonary hypertension in the future, helping people like you live better with the condition.

Key takeaways

The study uses a small sensor to measure walking in people with pulmonary hypertension.
It aims to see if sensor data matches traditional lung pressure measurements.
Participants wear the sensor three times for one week over 6-12 months.
No new medications are involved; it's an observational study.
The goal is to find easier ways to monitor the condition in the future.

Who may be eligible?

To join this study, you would need to be an adult (18 years or older) who has been diagnosed with pulmonary hypertension, specifically the type called precapillary pulmonary hypertension. This diagnosis would have been confirmed by a special heart test called a right heart catheterisation.

You should also be able to walk on your own without help and be able to walk at least 100 meters (about the length of a football pitch) in six minutes. Your overall health status, related to your lung condition, should be in a certain range (WHO Functional Class I-III). You also need to be able to understand the study and agree to take part, and be willing to wear a small sensor for about a week at a time.

You wouldn't be able to join if you've been in hospital recently for a lung problem (in the last 30 days), have another condition that makes walking difficult (like certain nerve or bone problems, or poor eyesight making you unsteady), or if you're experiencing severe pain that stops you from walking. Other reasons not to join include having a very short life expectancy, being treated for cancer, having severe mental health issues, or dependency on substances.

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 pulmonary hypertension diagnosed by a right heart catheterisation?
Can you walk on your own without needing help?
Can you walk at least 100 meters (about 110 yards) in six minutes?
Are you able and willing to wear a small sensor for about a week, three times over several months?
Have you not been in hospital for a lung problem in the last month?

Answer every question to see your result.

What does participation involve?

If you choose to participate, you will wear a small sensor on your lower back. You'll need to wear this sensor for one week at three different times: first when you join the study, then again at follow-up visits scheduled by your doctor (either 3-6 months later, and then again 6-12 months after that). These follow-up visits usually happen during your standard appointments. At the end of the study, you can choose to receive a summary of the measurements taken by your sensor. The total duration of your participation will depend on how your follow-up appointments are scheduled, but will generally involve wearing the sensor for three separate weeks over a period of 6 to 12 months.

Potential risks and benefits

Participating in this study might help improve how doctors monitor pulmonary hypertension in the future, potentially leading to simpler ways to track the condition. For you, there are no changes to your standard medical care, and wearing the sensor is not expected to cause any harm or pain, as it's a small, non-invasive device. The main commitment is remembering to wear the sensor for a week, three times, and attending your usual check-ups. You are free to withdraw from the study at any time without affecting your medical care.

Locations (4)

Robert Bosch Hospital
Verified postcode
Stuttgart, Germany· Recruiting
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Verified postcode
Munich, Germany· Recruiting
Klinikum Nuremberg
Verified postcode
Nuremberg, Germany· Recruiting
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Verified postcode
Löwenstein, Germany· Not yet recruiting

Common questions

What is pulmonary hypertension?

It's a condition where the blood pressure in the arteries leading from your heart to your lungs is too high. This makes your heart work harder.

What is a digital mobility outcome?

It's a way of measuring your walking and movement using a small, electronic sensor, like a fitness tracker, to understand how active you are.

Will I have to take any new medicine for this study?

No, this study does not involve any new medications. It's about monitoring your walking with a sensor.

What is a right heart catheterisation?

It's a medical procedure where a thin tube is guided into your heart to measure the pressure in your heart and lungs, helping doctors diagnose and monitor pulmonary hypertension.

Can I see my walking data?

Yes, at the end of the study, you will have the option to receive feedback on the information collected by your sensor.

How to find out more

Prof. Dr. med. Simon Jäger

simon.jaeger@klinikum-nuernberg.de +49 911-398-2822 Official trial record

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