Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Clinical trial phase IIb multicenter, double-blind, randomized, placebo-controlled trial evaluating the efficacy of intracoronary infusion of autologous adult mononuclear bone marrow unexpanded on functional recovery in patients with dilated cardiomyopathy of idiopathic origin and heart failure.

This study is investigating a new way to treat a specific type of heart condition called idiopathic dilated cardiomyopathy. This condition means your heart muscle is stretched and weakened without a clear cause. Researchers are trying to see if infusing a patient's own bone marrow cells directly into the heart can help it work better. This is a "Phase II" study, meaning it's still early in testing, but is exploring if the treatment works and is safe. Patients will either receive the cell treatment or a harmless dummy treatment (placebo), without knowing which one they're getting. Doctors will then carefully monitor heart function, general health, and any side effects to understand if this new approach could be a useful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud, Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud

Enrolment target

Start

08 Oct 2024

Idiopathic dilated cardiomyopathy

What is this study about?

You've been asked to consider taking part in a research study about a heart condition called idiopathic dilated cardiomyopathy. Put simply, this is a type of heart weakness where the heart muscle becomes enlarged and struggles to pump blood effectively, and doctors aren't sure why it happened. This study aims to explore a new treatment idea using your own body's cells.

The main goal of this study is to see if giving patients their own bone marrow cells directly into the heart can help improve how well the heart works. Your bone marrow is like a factory for many types of cells, including some that might help repair or improve damaged tissue. Doctors want to find out if these cells can help the heart recover and pump more efficiently.

This is a 'Phase II' study, which means it's an early-stage investigation. Researchers are trying to understand if this treatment is effective and safe before it can be considered for wider use. By taking part, you would help doctors learn more about this condition and potentially discover new ways to help patients in the future.

Key takeaways

This study explores using your own bone marrow cells to improve a weakened heart.
It's a 'Phase II' study, focusing on whether the treatment is effective and safe.
Half of participants will receive the active cell treatment, and half will receive a dummy treatment.
The study involves procedures to collect bone marrow and infuse cells/placebo into your heart.
Regular follow-up appointments will track your heart function and overall health.

Who may be eligible?

This study is open to both men and women aged 18 years and older who have been diagnosed with idiopathic dilated cardiomyopathy, which means your heart muscle is weakened and enlarged without a known cause. Doctors will review your specific heart condition and overall health to make sure this study is a good fit for you.

There will be certain health criteria that mean you might not be able to join the study. These could include other serious medical conditions or certain medications you are taking that might interfere with the study's results or your safety. The study team will carefully explain all the requirements and discuss if you meet them.

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?
Have you been diagnosed with idiopathic dilated cardiomyopathy?
Are you able to attend regular follow-up appointments?
Do you understand that you might receive a dummy treatment (placebo)?
Are you comfortable undergoing procedures to collect bone marrow and infuse treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a procedure where doctors would collect some bone marrow from you. This is usually taken from a hip bone under local anaesthetic or light sedation. Then, you would have a separate procedure where either your prepared bone marrow cells or a dummy treatment (placebo) would be infused into your heart. You wouldn't know which one you received.

After these initial procedures, you would have regular check-ups with the study team. These visits would include standard heart tests like echocardiograms (ultrasound of the heart), blood tests, and possibly another heart catheterisation to see how your heart function is changing. You would also have check-ups to assess your general health, how you feel, and your ability to do physical activities, possibly including a simple exercise test. The study team would also call you periodically to check on your well-being. The total duration of your participation, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might not directly benefit from this study, as the main goal is to learn more about the treatment. However, your participation could help future patients with dilated cardiomyopathy. Potential risks might include those associated with the bone marrow collection procedure, the heart infusion procedure itself (like any medical procedure), and possible side effects from the cells or the dummy treatment, although these are carefully monitored. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is idiopathic dilated cardiomyopathy?

It's a heart condition where your heart muscle becomes stretched and weakened, making it harder to pump blood effectively, and the cause isn't known.

What are bone marrow cells?

These are special cells found inside your bones that can develop into different types of cells, and some might have properties that help repair or improve damaged tissues.

What does 'double-blind' mean?

It means neither you nor your study doctors will know if you received the active cell treatment or the dummy treatment (placebo) until after the study is complete. This helps ensure fair results.

Will I have to stay in the hospital?

You would likely need to be in the hospital for the procedures to collect your bone marrow and infuse the treatment. Subsequent check-ups will mostly be outpatient visits.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real treatment but has no active ingredients. It's used to compare against the active treatment.