Effects of DAPAgliflozin on cardiopulmonary exercise capacity and hemodynamics in Pulmonary Arterial Hypertension: A double blind randomized trial. (DAPAH-trial)
This study, called the DAPAH-trial, is testing a medicine named Forxiga (dapagliflozin) for patients with chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. These conditions cause high blood pressure in the arteries leading to the lungs. We're trying to find out if Forxiga can improve how well people can exercise, specifically by measuring their maximum oxygen use during activity. This is a phase 2 trial, meaning it's an early stage of testing to see if the medicine is helpful and safe. Half of the participants will receive Forxiga, and the other half will get a dummy pill (placebo) to help us compare the effects accurately. The study lasts for ninety days.
At a glance
What is this study about?
This research study is called the DAPAH-trial, and it's looking into a medicine named Forxiga (dapagliflozin) for people who have special types of high blood pressure in their lungs. These conditions are called chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. In simple terms, this means the blood vessels in the lungs are narrowed or blocked, making it harder for the heart to pump blood through them. This can lead to symptoms like breathlessness and tiredness.
The main goal of this study is to see if Forxiga can help people with these conditions to exercise better. We'll measure this by looking at how much oxygen their body uses when they're at their most active. We also want to understand how the medicine affects the heart and lung system, including things like blood pressure in the lungs and how well the heart is pumping. The study lasts for about three months.
This is a 'Phase 2' study, which means it's an earlier stage of testing. We're trying to find out if Forxiga is a promising treatment and if it's generally safe for people with these lung conditions. The results of this study will help us decide if it's worth doing bigger studies in the future.
Key takeaways
- The study is testing a medicine called Forxiga for high blood pressure in the lungs.
- It aims to see if Forxiga improves exercise ability and heart/lung function.
- You might receive the active medicine or a dummy pill (placebo).
- Participation involves regular clinic visits and tests over about three months.
- The study is an early-stage test to gather important information.
Who may be eligible?
To be able to take part in this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also participate.
Both men and women are welcome to join the study.
More specific details about your health condition, other medicines you might be taking, or previous treatments you've had will need to be checked by the study team to make sure this trial is the right 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 18 years old or older?
- Do you have chronic thromboembolic pulmonary hypertension or pulmonary arterial hypertension?
- Are you able to attend regular clinic appointments for about three months?
- Are you willing to undergo exercise tests and other health assessments?
- Are you able to take study medication (pills) as directed?
What does participation involve?
If you join this study, you'll be given either the study medicine, Forxiga (dapagliflozin), or a dummy pill (placebo) to take. Neither you nor your study doctor will know which you're receiving – this is called a 'double-blind' study and helps make the results fair.
You'll have several visits to the clinic over about three months. At these appointments, you'll have various tests to check your health and how your heart and lungs are working. One key test will be a 'cardiopulmonary exercise test', which involves exercising while hooked up to equipment that measures your breathing and oxygen use. You'll also likely have blood tests and other examinations like a 6-minute walking test, where we see how far you can walk in six minutes, and heart scans (echocardiograms).
The study medicine or placebo will be taken for ninety days. After this period, there will be follow-up appointments to see how you're doing and to complete all the necessary measurements. The total duration of your active involvement in the study, including all tests and follow-ups, will be around three months.
Potential risks and benefits
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Common questions
What is pulmonary hypertension?
It's when you have high blood pressure in the arteries that go from your heart to your lungs, making your heart work harder.
What is Forxiga (dapagliflozin) and what does it do?
Forxiga is a medicine currently used for other conditions, and in this study, we're exploring if it can help improve how the heart and lungs work for people with pulmonary hypertension.
What is a 'placebo'?
A placebo is a dummy pill that looks just like the study medicine but contains no active drug. It helps us see if the medicine truly has an effect.
What is a 'cardiopulmonary exercise test'?
This is a special test where you exercise on a bike or treadmill while equipment measures your breathing and how much oxygen your body uses, to see how well your heart and lungs are working together.
How long will I be in the study?
The study involves taking the medicine or placebo for ninety days (about three months), with assessments before, during, and after this period.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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