Not recruitingRare disease

Study on Dapagliflozin for Patients with Pulmonary Arterial Hypertension to Improve Exercise Capacity and Heart Function

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication dapagliflozin, also known as Forxiga, in patients with a condition called Pulmonary Arterial Hypertension (PAH). PAH is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. The study also includes patients with Chronic Thromboembolic Pulmonary Hypertension, which is a related condition. The purpose of the study is to evaluate how dapagliflozin affects exercise capacity and heart and lung function in patients who are already receiving other treatments for PAH.

Participants in the study will be randomly assigned to receive either dapagliflozin or a placebo, which is a tablet that looks like the medication but does not contain the active ingredient. The study will last for about three months, during which participants will take the tablets by mouth. Throughout the study, various tests will be conducted to assess changes in exercise ability, heart and lung function, and other health indicators. These tests will help researchers understand the impact of dapagliflozin on the body.

The study aims to provide valuable information on whether dapagliflozin can improve the health and quality of life for people with PAH. By comparing the effects of the medication with the placebo, researchers hope to determine its effectiveness and safety in managing this challenging condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their well-being and to gather accurate data on the medication's effects.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the medication dapagliflozin or a placebo. A placebo is a tablet that looks like the medication but does not contain any active ingredients.
The study is double-blind, meaning neither you nor the study team will know which treatment you are receiving to ensure unbiased results.
Step 2
Medication administration
You will take one Forxiga 10 mg film-coated tablet or a placebo tablet orally each day. This will continue for a period of ninety days.
It is important to take the tablet at the same time each day to maintain consistency in the study.
Step 3
Initial assessments
At the beginning of the study, you will undergo a series of assessments to establish a baseline. These assessments include a cardiopulmonary exercise test to measure your maximum oxygen consumption, known as VO2 max.
Additional tests will measure your walking distance over six minutes, your heart and lung function, and other health indicators.
Step 4
Ongoing monitoring
Throughout the study, you will have regular check-ups to monitor your health and any changes in your condition. This includes repeating some of the initial assessments.
You will be asked to report any side effects or changes in your health to the study team immediately.
Step 5
Final assessments
At the end of the ninety-day period, you will undergo the same assessments as at the beginning of the study to evaluate any changes in your condition.
The results will help determine the effects of dapagliflozin compared to the placebo on your exercise capacity and heart and lung function.

Who can join the trial?

10 criteria

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Must have a diagnosis of pulmonary arterial hypertension (PAH) in one of the following types:
- Idiopathic PAH (iPAH) - PAH with no known cause
- Heritable PAH (hPAH) - PAH that runs in families
- Connective tissue disease associated PAH (aPAH) - PAH linked to diseases affecting connective tissues
- If diagnosed with PAH in group 4, no further invasive treatments like pulmonary endarterectomy (surgery to remove blockages in lung arteries) or pulmonary balloon angioplasty (procedure to open blocked lung arteries) should be planned at the time of joining the study.
- Must have symptoms of PAH that are classified as WHO functional class II-III, which means experiencing slight to moderate limitations in physical activity.
- Must be clinically stable on pulmonary vasodilator treatment (medications that help open blood vessels in the lungs) for at least four weeks, without any recent worsening of symptoms or unplanned hospital visits due to PAH in the last three months.
- Women who can have children (under 50 years old) must use reliable birth control methods like an intrauterine device (IUD) or hormonal contraception during the study and have a negative pregnancy test.
- Must be able to understand written information in Danish and provide informed consent to participate.
- Must be 18 years of age or older.
- Must be able to perform a cardiopulmonary exercise test, which is a test to measure how well the heart and lungs work during physical activity.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have had a heart attack or stroke in the last 6 months.
Patients with severe liver disease.
Patients with severe kidney disease.
Patients who are currently participating in another clinical trial.
Patients who have a history of drug or alcohol abuse.
Patients who have an allergy to the study medication or similar drugs.
Patients who have uncontrolled high blood pressure.
Patients who have been diagnosed with cancer in the last 5 years, except for skin cancer that is not melanoma.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Dapagliflozin is a medication used in this trial to help improve heart and lung function in patients with Pulmonary Arterial Hypertension (PAH). It works by helping the body remove excess sugar through urine, which can also help reduce the workload on the heart and improve blood flow. In this study, researchers are looking at how this medication affects exercise capacity and heart function in patients who are already receiving other treatments for PAH.

What is already known about the treatment

Forxiga® – Forxiga, also known as dapagliflozin, is administered orally in the form of tablets. It is currently being studied in clinical trials for its effects on patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension. The main therapeutic use of Forxiga in this context is to improve exercise capacity and heart and lung function in these patients. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys, which helps to remove excess glucose from the body, though its exact mechanism in PAH is still under investigation. It is classified as a sodium-glucose co-transporter 2 (SGLT2) inhibitor.

Investigated diseases

Chronic thromboembolic pulmonary hypertension
This disease is characterized by high blood pressure in the lungs' arteries due to blood clots that have not been fully resolved. Over time, these clots can lead to scarring and narrowing of the pulmonary arteries, which increases resistance to blood flow. As the condition progresses, the heart must work harder to pump blood through the lungs, which can lead to right heart enlargement and dysfunction. Symptoms often include shortness of breath, fatigue, and chest pain, which may worsen with physical activity. The disease can develop slowly, and its progression can vary among individuals.
Pulmonary arterial hypertension
This condition involves elevated blood pressure in the pulmonary arteries, which are the vessels that carry blood from the heart to the lungs. It is caused by the narrowing or blockage of these arteries, leading to increased resistance to blood flow. As the disease progresses, the right side of the heart becomes strained and may enlarge or weaken. Common symptoms include shortness of breath, dizziness, and swelling in the legs or abdomen. The progression of the disease can lead to reduced exercise capacity and increased fatigue over time.