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Study on the Effects of Inhaled Nitric Oxide on Heart and Lung Function After Cardiac Surgery

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 patients who have just undergone cardiac surgery. The study aims to explore the effects of a treatment using a medicinal gas called VasoKINOX, which contains nitric oxide. This gas is inhaled and is being studied for its potential benefits on the heart's right side and the blood vessels in the lungs after surgery.

The purpose of the study is to understand how inhaled nitric oxide affects the heart's ability to pump blood and the blood flow in the lungs. The study will observe patients who are in the recovery phase right after their heart surgery. During the study, some patients will receive the inhaled gas, while others may receive a placebo. The effects on heart function and lung blood flow will be monitored to gather important information.

Participants in the study will be closely observed to see how their heart and lungs respond to the treatment. The study will help researchers learn more about the potential benefits of using nitric oxide in patients recovering from heart surgery, which could lead to improved care and outcomes in the future.

The research process

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

  1. Step 1

    Joining the study

    Participation begins after cardiac surgery during the immediate post-operative period.

    Eligibility includes being over 18 years old, having stable heart rhythm, and being under passive mechanical ventilation.

  2. Step 2

    Administration of medication

    The medication used is VasoKINOX 800 ppm mol/mol, a medicinal gas containing nitric oxide.

    The gas is administered through inhalation.

  3. Step 3

    Monitoring and evaluation

    The main objective is to study the effects of inhaled nitric oxide on pulmonary vascular mechanics and right ventricular function.

    Primary evaluation focuses on parameters of right ventricular function.

    Secondary evaluation includes results from electrical impedance tomography, assessing regional distribution of ventilation and perfusion.

  4. Step 4

    Completion of participation

    The trial is estimated to end by December 31, 2027.

    Participation concludes after the necessary data is collected and analyzed.

Who can join the trial?

7 criteria

  • The patient must have given their permission to participate, known as informed consent.
  • The patient must be older than 18 years.
  • The patient must be on passive mechanical ventilation, which means a machine is helping them breathe.
  • The patient must have a pre-operative FEVI of at least 30%. FEVI is a measure of how well the lungs are working.
  • The patient must not have hypovolemia, which means they should not have a low blood volume. This is checked by ensuring there is no ventricular "kissing" and the superior vena cava collapsibility index is less than 20%.
  • The patient must have a stable natural heart rhythm, meaning their heart beats regularly on its own.
  • The patient must have stable hemodynamic conditions after surgery, meaning their blood flow and blood pressure are stable.

Who cannot join the trial?

4 criteria

  • Patients who are not in the immediate period after heart surgery cannot participate.
  • Individuals who are not within the specified age range for the study are excluded. The age range is not specified here, but it is important for eligibility.
  • Both males and females are eligible, so gender is not an exclusion factor.
  • Vulnerable populations, which may include groups like children or those unable to consent, are not specifically excluded, but the study does not focus on them.
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Investigated drugs

Inhaled Nitric Oxide (iNO) is a gas that is used in this clinical trial to help improve the function of the heart and lungs after cardiac surgery. It is inhaled through a mask or breathing tube and works by relaxing the blood vessels in the lungs. This can help reduce the pressure in the lungs and improve the flow of blood from the heart to the lungs. The goal of using inhaled nitric oxide in this trial is to see if it can help the heart work better and improve recovery after surgery.

What is already known about the treatment

Nitric Oxide (inhaled) – This medication is administered through inhalation, typically using a specialized delivery system. It is currently being studied in clinical trials to assess its effects on right ventricular function and pulmonary vascular mechanics in patients who have just undergone cardiac surgery. The main therapeutic indication is to support heart and lung function immediately after surgery. At the molecular level, nitric oxide works by relaxing the smooth muscles in blood vessels, leading to vasodilation and improved blood flow. It is classified as a vasodilator in pharmacology.

Investigated diseases

Postoperative Cardiac Surgery Condition – This condition occurs in patients who have recently undergone cardiac surgery. It involves the immediate recovery phase where the heart and surrounding structures are adjusting to the changes made during surgery. Patients may experience alterations in heart function, particularly affecting the right side of the heart. The condition can influence how well the heart pumps blood and how the blood vessels in the lungs respond. Monitoring and managing the heart's function and the blood flow in the lungs are crucial during this period. The focus is on ensuring the heart and lungs work together effectively as the body heals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520808-10-00Estimated enrolment50 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa

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