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Study on Vitamin D and Oral Iron for Patients with Chronic Heart Failure 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 clinical trial is focused on patients with chronic heart failure and iron deficiency. The study aims to evaluate the effectiveness of combining vitamin D with an oral iron supplement called sucrosomial iron compared to an intravenous iron treatment known as ferric carboxymaltose. The goal is to see if the combination of vitamin D and sucrosomial iron can improve heart failure symptoms as effectively as ferric carboxymaltose.

Participants in the study will receive either the vitamin D and sucrosomial iron combination or the ferric carboxymaltose treatment. The study will last for 24 weeks, during which the effects of these treatments on heart failure symptoms will be monitored. The main focus will be on the distance participants can walk in six minutes, which is a common way to assess physical ability in heart failure patients. Other aspects, such as quality of life and heart function, will also be evaluated.

The study will help determine if the oral combination of vitamin D and sucrosomial iron is a viable alternative to the intravenous iron treatment for improving the health of patients with chronic heart failure and iron deficiency. This research could provide valuable insights into more accessible treatment options for managing these conditions.

The research process

The trial runs in 6 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, eligibility is confirmed based on specific criteria such as having stable chronic heart failure and iron deficiency.
Participants must have been stable for at least three weeks since the last hospitalization or emergency department visit for heart failure.
Step 2
Initial assessment
An initial assessment is conducted to evaluate heart function and iron levels.
This includes tests like the Six-Minute Walking Test to measure physical capacity.
Step 3
Treatment phase
Participants receive either a combination of vitamin D and oral iron or intravenous ferric carboxymaltose.
The treatment lasts for 24 weeks, with regular monitoring of symptoms and health status.
Step 4
Medication details
The oral iron is administered in combination with vitamin D, while the alternative treatment involves intravenous injections of ferric carboxymaltose.
The specific dosage and frequency are determined by the study protocol and monitored by the research team.
Step 5
Ongoing assessments
Throughout the study, regular assessments are conducted to monitor heart function and overall health.
These assessments include questionnaires, echocardiograms, and blood tests to evaluate various health parameters.
Step 6
Completion of the study
At the end of the 24-week treatment period, a final assessment is conducted to evaluate the effectiveness of the treatment.
The primary measure of success is the improvement in the Six-Minute Walking Test distance.

Who can join the trial?

12 criteria

Have chronic heart failure with symptoms that are stable. This means your condition is not getting worse quickly.
Be in NYHA functional class II-III, which means you have some limitations in physical activity due to heart failure.
Have not been in the hospital or emergency room for heart failure in the last 3 weeks.
Be on the best possible medication for heart failure as recommended by heart specialists, unless you cannot take it or it causes side effects.
No changes in heart failure medication dose in the last 2 weeks, except for water pills (diuretics).
No new heart failure medications started in the last 3 weeks.
Have a left ventricle ejection fraction of 45% or less. This is a measure of how well your heart pumps blood.
Have a brain natriuretic peptide level greater than 100 pg/mL or an N-terminal-pro-brain natriuretic peptide level greater than 400 pg/mL. These are blood tests that show how severe your heart failure is.
Show signs of iron deficiency, which means having a ferritin level less than 100 ng/mL or a TSAT (transferrin saturation) less than 20% if ferritin is between 100 and 300 ng/mL. Ferritin and TSAT are measures of iron in your body.
Have vitamin D levels less than 50 nmol/L.
Be able to complete a 6-Minute-Walking Test, which is a simple test to see how far you can walk in 6 minutes.
Be at least 18 years old.

Who cannot join the trial?

3 criteria

Patients who do not have chronic heart failure or iron deficiency cannot participate. Chronic heart failure is a condition where the heart doesn't pump blood as well as it should. Iron deficiency means having lower than normal levels of iron in the body, which is important for making red blood cells.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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Azienda Ospedaliera di Padova
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Padua, Italy

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Investigated drugs

Vitamin D
is a supplement used in this trial to help improve the health of patients with chronic heart failure and iron deficiency. It is combined with iron to see if it can help improve heart failure symptoms.
Sucrosomial Iron
is a form of iron supplement used in this study. It is taken orally and is being tested to see if it is as effective as another form of iron given through an IV in improving symptoms of heart failure in patients with iron deficiency.
Ferric Carboxymaltose
is an iron supplement given through an intravenous (IV) infusion. In this trial, it is used as a comparison to see if the oral iron supplement, sucrosomial iron, combined with vitamin D, can be just as effective in treating patients with chronic heart failure and iron deficiency.

What is already known about the treatment

Vitamin D
This medication is administered orally and is being studied for its potential benefits in combination with iron supplements for patients with chronic heart failure and iron deficiency. Currently, vitamin D is well-documented in medical literature for its role in bone health and immune function, but its effects in heart failure are still under investigation. The main therapeutic indication in this trial is to improve symptoms of heart failure when combined with iron. Vitamin D works by helping the body absorb calcium and may have additional roles in heart muscle function. It is classified as a vitamin supplement.
Sucrosomial Iron
This medication is taken orally and is being evaluated for its effectiveness in treating iron deficiency in patients with chronic heart failure. It is a newer form of iron supplement that is designed to be better absorbed in the digestive system. The main therapeutic indication is to address iron deficiency, which can worsen heart failure symptoms. Sucrosomial iron works by providing iron in a form that is more easily absorbed by the body, potentially leading to improved energy levels and reduced fatigue. It is classified as an iron supplement.
Ferric Carboxymaltose
This medication is administered intravenously and is used to treat iron deficiency in patients with chronic heart failure. It is well-established in medical practice and literature for its effectiveness in quickly replenishing iron stores in the body. The main therapeutic indication is to improve symptoms of heart failure by correcting iron deficiency. Ferric carboxymaltose works by delivering iron directly into the bloodstream, bypassing the digestive system, which allows for rapid absorption and utilization by the body. It is classified as an iron supplement.

Investigated diseases

Chronic Heart Failure
This condition occurs when the heart is unable to pump blood effectively, leading to a buildup of fluid in the lungs and other parts of the body. Over time, this can cause symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The heart's reduced ability to pump blood can result from damage to the heart muscle, often due to a heart attack or high blood pressure. As the condition progresses, the heart may become enlarged, and its walls may thicken or stiffen. This can further impair the heart's function and exacerbate symptoms. Management focuses on improving the heart's efficiency and reducing symptoms.
Iron Deficiency
This condition arises when the body lacks sufficient iron to produce adequate levels of hemoglobin, the protein in red blood cells that carries oxygen. It can lead to symptoms such as fatigue, weakness, and pale skin. Iron deficiency often develops gradually and may be caused by inadequate dietary intake, increased iron needs during pregnancy, or chronic blood loss. As the deficiency progresses, it can result in anemia, where the blood has a reduced capacity to carry oxygen. This can further exacerbate symptoms and affect overall health. Addressing the underlying cause and replenishing iron stores are key to managing this condition.