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A Study of Ferric Carboxymaltose to Improve Exercise Ability in Patients with Pulmonary Hypertension and Iron Deficiency

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What is this trial about?

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

This study looks at two conditions: iron deficiency and pulmonary hypertension. Iron deficiency means the body does not have enough iron, which is an important mineral needed for many body functions. Pulmonary hypertension is a condition where the blood pressure in the arteries of the lungs is too high, which can make it hard to breathe and do everyday activities. The study will test a treatment called ferric carboxymaltose, which is a medicine that provides iron to the body and is given through a vein. Some patients will receive ferric carboxymaltose while others will receive placebo, which is a substance that looks like the medicine but does not contain the active treatment. The medicine will be given by intravenous injection or infusion, which means it goes directly into a vein.

The purpose of this study is to find out if treating patients who have pulmonary hypertension and iron deficiency with ferric carboxymaltose improves their ability to exercise compared to those who receive placebo. The study will measure this by looking at changes in how far patients can walk in six minutes, which is a common way to check exercise ability in people with heart and lung conditions. The study will also look at other aspects such as quality of life, heart failure symptoms, and fatigue levels to see if the treatment helps patients feel better overall.

During the study, patients will be randomly assigned to receive either ferric carboxymaltose or placebo over a treatment period of up to four weeks. The study is double-blind, which means neither the patients nor the doctors will know who is receiving the actual medicine or placebo during the treatment. Patients will be followed for 24 weeks to see how well the treatment works. The study includes patients with different types of pulmonary hypertension, and all participants must have iron deficiency confirmed by blood tests before joining the study.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment administration
At the start of the trial, you will receive your first dose of the assigned treatment. This will be either ferric carboxymaltose (an iron replacement medication) or a placebo (an inactive substance). The treatment will be given through an intravenous infusion, which means it will be administered directly into your vein.
The dosage of ferric carboxymaltose will be determined according to standard medical guidelines. The treatment also contains sodium chloride, which is used as a solution to deliver the medication safely into your bloodstream.
Neither you nor your doctor will know which treatment you are receiving during the trial, as this is a double-blind study designed to ensure accurate results.
Step 2
Follow-up period and assessments
You will be followed for 24 weeks after starting the treatment. During this period, your exercise capacity and functional status will be monitored.
Your exercise capacity will be measured using a 6-minute walking distance test. This test measures how far you can walk in 6 minutes and will be performed at the beginning of the trial and again at 24 weeks to assess any changes.
You will also complete several questionnaires to evaluate your quality of life and symptoms. These include the EQ5D (a general health questionnaire), the MLHFQ (Minnesota Living with Heart Failure Questionnaire, which assesses how heart failure affects your daily life), and the FSS (Fatigue Severity Scale, which measures your level of tiredness).
Throughout the trial period, your medical team will monitor for any clinical worsening events or changes in your condition.
Step 3
Continuation of standard care
During the trial, you will continue taking your regular medications for pulmonary hypertension or heart failure. These medications must remain at stable doses for at least 4 weeks before you start the trial and throughout the study period.
If you have been prescribed loop diuretics or other heart failure medications, you should continue taking them as directed by your doctor without changes in dosage.
Step 4
Final assessment at 24 weeks
At the end of the 24-week follow-up period, you will undergo final assessments. These will include repeating the 6-minute walking distance test and completing the health questionnaires again.
The results from these final assessments will be compared to your initial measurements to determine whether the treatment had an effect on your exercise capacity and functional status.

Who can join the trial?

8 criteria

You must be 18 years of age or older
You must have iron deficiency, which means your body does not have enough iron. This is measured by a blood test showing TSAT (transferrin saturation, which shows how much iron is in your blood) of less than 21 percent
You must have pulmonary hypertension, which is high blood pressure in the blood vessels of your lungs. This must be confirmed by special heart tests such as an echocardiography (an ultrasound of your heart) or right heart catheterization (a test where a thin tube is inserted into your heart to measure pressure)
Your symptoms must be classified as WHO functional class II, III, or IV, which describes how much your condition affects your daily activities
If you have Group 1 pulmonary hypertension (also called pulmonary arterial hypertension or PAH), you must have been taking stable doses of specific lung blood pressure medicines for at least 4 weeks before joining the study
If you have Group 2 pulmonary hypertension related to heart problems with preserved heart pump function, your LVEF (left ventricular ejection fraction, which measures how well your heart pumps blood) must be greater than 50 percent, and you must have been on stable doses of water pills and heart medicines for 4 weeks
If you have Group 4 pulmonary hypertension caused by blood clots in your lungs (CTEPH), you must either not be able to have surgery or still have the condition after previous treatments
Your pulmonary hypertension must meet specific measurement criteria on your heart tests

Who cannot join the trial?

1 criterion

No exclusion criteria have been provided in the available study information

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Verified sites

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Algemeen Stedelijk Ziekenhuis Campus Aalst
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Aalst, Belgium
Katholieke Universiteit te Leuven
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Leuven, Belgium
Université Libre de Bruxelles - Hôpital Erasme
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Brussels, Belgium

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Investigated drugs

Ferric carboxymaltose
is an iron replacement medication given through an intravenous infusion (directly into a vein). It is used to treat iron deficiency, a condition where the body does not have enough iron. In this trial, it is being tested to see if correcting iron deficiency can help improve exercise ability and how well patients with pulmonary hypertension can perform daily activities.
Placebo
is an inactive substance that looks like the real medication but contains no active treatment. It is used in the trial to compare against ferric carboxymaltose to determine if the real medication is actually working.

What is already known about the treatment

Ferric Carboxymaltose – This medication is given through an intravenous infusion directly into a vein, typically administered in a hospital or clinic setting by a healthcare professional. It is an approved iron replacement therapy used to treat iron deficiency in various patient populations, including those who cannot tolerate oral iron supplements or need rapid iron replenishment. The drug works by delivering iron directly into the bloodstream, where it is taken up by cells and used to produce hemoglobin and restore the body's iron stores, which are essential for oxygen transport and energy production. In this clinical trial, researchers are investigating whether correcting iron deficiency with this medication can improve exercise capacity and physical function in patients suffering from pulmonary hypertension, a condition characterized by high blood pressure in the lungs.

Investigated diseases

Iron Deficiency
Iron deficiency is a condition where the body does not have enough iron to produce adequate amounts of hemoglobin, a protein in red blood cells that carries oxygen throughout the body. This deficiency can develop gradually over time as the body's iron stores become depleted. When iron stores are low, the body cannot make enough healthy red blood cells, leading to reduced oxygen delivery to tissues and organs. Common symptoms include fatigue, weakness, pale skin, shortness of breath, and difficulty concentrating. The condition can progress from mild depletion of iron stores to more severe stages where it affects the production and function of red blood cells. Iron deficiency can occur due to inadequate dietary intake, poor absorption of iron, or increased iron loss from the body.
Pulmonary Hypertension
Pulmonary hypertension is a condition characterized by abnormally high blood pressure in the arteries of the lungs. The increased pressure occurs when the small blood vessels in the lungs become narrowed, blocked, or damaged, making it harder for blood to flow through them. As a result, the right side of the heart must work harder to pump blood through the lungs, which can weaken the heart muscle over time. Common symptoms include shortness of breath during routine activities, fatigue, chest pain, and a racing heartbeat. As the condition progresses, patients may experience increased difficulty with physical activities and reduced exercise capacity. The disease can develop from various underlying causes and may worsen gradually, affecting the ability to perform daily tasks.