AuthorisedTherapeutic confirmatory (Phase III)Interventional

Role of inhaled nitric oxide on right ventricular function and pulmonary vascular mechanics following cardiac surgery

This research is investigating a special medical gas called VasoKINOX, which is similar to nitric oxide naturally found in your body. The study aims to understand if breathing in this gas helps the right side of your heart and improves how blood flows through your lungs after you've had heart surgery. Doctors are looking closely at how well the right side of the heart is working as the main focus. They are also checking how well air and blood are spread around in the lungs using a special scanning technique. The goal is to see if this gas can help patients recover better after their operation. It's a key stage of research to confirm if this treatment is effective.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

Enrolment target

Start

24 Jan 2025

Patients in the immediate cardiac surgery post-operative period

What is this study about?

Imagine your heart as a pump with different sections. After heart surgery, the right side of your heart can sometimes struggle a bit. This study is looking at a medical gas, called VasoKINOX, which is a lot like nitric oxide, a natural gas your body already produces. We know that nitric oxide can help relax blood vessels.

The main idea behind this study is to see if giving patients this gas straight after heart surgery can help the right side of their heart pump more easily. When the right side of the heart works better, it can help the body recover more smoothly. The study is also trying to understand how this gas affects the tiny blood vessels in the lungs, making sure that air and blood are distributed well to help with breathing.

This is a 'Phase III' study, which means it's a very important step to confirm if this treatment really works and is safe for patients. The results from this study will help doctors understand if VasoKINOX could become a standard treatment to help people recover after heart surgery. We'll be looking closely at how the heart works and also using special equipment to see what's happening inside the lungs.

Key takeaways

The study tests a gas (VasoKINOX) after heart surgery.
It aims to help the heart's right side work better.
It also checks blood flow and air distribution in the lungs.
This is a key study to confirm if the treatment is effective.
It is for adults who have recently had heart surgery.

Who may be eligible?

This study is for adults who have just had heart surgery. To join, you need to be at least 18 years old. There's no upper age limit, so people of all adult ages can be considered.

Both men and women can take part in this research study. The doctors and nurses running the study will carefully check if this study is right for you, based on your health after your surgery.

They will need to make sure that taking part is safe for you and that the study can properly measure what they are trying to find out. A medical team will review your specific situation to see if you meet all the necessary requirements.

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 recently had heart surgery?
Are you comfortable potentially receiving a new investigational gas treatment?
Are you able to stay in the hospital for the recovery period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study gas (VasoKINOX) through a breathing device shortly after your heart surgery. The medical team would closely monitor your heart's function using standard hospital tests. They will also use a special, non-invasive scan called Electrical Impedance Tomography (EIT) which is like an electrical map of your lungs, to see how air and blood are moving. This helps them understand how the gas is affecting your lungs. You won't need extra hospital visits beyond your normal post-surgery care. The entire time you are receiving the gas and being monitored would be part of your immediate recovery period in the hospital.

Potential risks and benefits

Taking part might offer the potential benefit of helping your heart and lungs recover better after surgery, but this is what the study is trying to find out. It's also possible there might be no direct benefit to you. As with any medical treatment, there could be some risks or side effects from the study gas, which your doctor will discuss with you. You will be very closely monitored by the medical team. If you decide to join, you are always free to change your mind and leave the study at any time, without it affecting your medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is VasoKINOX?

VasoKINOX is a medical gas similar to nitric oxide, which your body naturally produces to help relax blood vessels.

Why is this gas given?

It's given to see if it can help the right side of your heart work better and improve blood flow in your lungs after heart surgery.

Who can join the study?

Adults aged 18 and over, both men and women, who have just had heart surgery can be considered.

How will they check my lungs?

They will use a special, safe scan called Electrical Impedance Tomography (EIT) to see how air and blood are moving in your lungs.

Will I have extra appointments?

No, any monitoring or treatment will be part of your normal recovery time in the hospital after your surgery.