A Study of High-Concentration Oxygen Treatment in Patients with Heart Failure, Pulmonary Hypertension, and Coronary Microvascular Dysfunction

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What is this study about?

This study focuses on several heart and lung conditions including Pulmonary Hypertension, Coronary Microvascular Dysfunction, Heart Failure, and conditions involving low oxygen levels in the body (Hypoxia). The study aims to understand how high-concentration oxygen affects blood flow and blood vessel resistance in different parts of the body, particularly in the heart and lungs.

The treatment being studied is Conoxia, which is a medical-grade oxygen given in its liquid, extremely cold form (cryogenic). This pure oxygen will be administered to participants to examine its effects on blood circulation. The study will measure how the heart pumps blood and how blood vessels respond to this oxygen treatment.

During the study, measurements will be taken at different time points to see how quickly the body responds to the oxygen treatment. The study will look at blood flow changes in various parts of the body, including the heart’s small blood vessels and the blood vessels in the lungs. These measurements will help understand how oxygen treatment affects blood circulation throughout the body.

1 Initial procedures

Your participation begins with a standard heart catheterization procedure, which has been determined as clinically necessary for your condition

This procedure will help examine blood flow in your heart vessels and measure blood pressure in your heart and lungs

2 Oxygen administration

You will receive 100% oxygen through oral delivery

The oxygen will be administered in its liquid form (medical grade, cryogenic)

The administration will last for 10 minutes

3 Measurements

Blood flow measurements will be taken at three specific points:

At the beginning of the procedure (baseline)

5 minutes after starting oxygen administration

10 minutes after starting oxygen administration

4 Monitored parameters

During the procedure, several measurements will be taken:

Blood flow output from your heart

Blood pressure in your heart and lung vessels

Blood vessel resistance in your heart and lungs

These measurements will help understand how oxygen affects blood flow in your vessels

5 Duration

The entire procedure will be completed during your scheduled heart catheterization

No additional visits will be required beyond your regular medical appointment

Who Can Join the Study?

  • Must be at least 18 years old
  • Must be scheduled for one of these medical procedures:
    • Coronary Flow Test (CFT) showing problems with small blood vessels in the heart
    • Right Heart Catheterization (RHC) to check for high blood pressure in the lungs
    • Left and Right Heart Catheterization as part of evaluation for heart transplant or mechanical heart pump
  • Must have clear coronary arteries (no significant blockages in heart blood vessels – less than 50% narrowing)
  • Must be able to understand and willing to sign an informed consent form
  • Can be either male or female

Who Cannot Join the Study?

  • Age under 18 or over 65 years old
  • Pregnancy or breastfeeding
  • Severe pulmonary diseases (diseases affecting the lungs) other than those being studied
  • Recent heart attack or unstable heart conditions
  • Inability to lie flat for the duration of the examination
  • Current participation in other clinical trials
  • Known allergies to medications used in the study
  • Severe kidney or liver dysfunction
  • Uncontrolled high blood pressure
  • History of blood clotting disorders
  • Mental conditions that could affect ability to provide informed consent
  • Active infections or fever
  • Use of medications that could interfere with the study results
  • Inability to follow study procedures
  • History of adverse reactions to oxygen therapy

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Stichting Radboud University Medical Center Nijmegen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.10.2024

Trial locations

Investigated drugs:

Oxygen (100% concentration) – Pure oxygen administered as a medical gas. This therapy involves breathing in oxygen at high concentration levels. It’s commonly used to increase the amount of oxygen in the blood. During this study, researchers are examining how this high concentration of oxygen affects blood flow and blood vessel resistance in different parts of the body, including the heart, lungs, and throughout the circulatory system.

Investigated diseases:

Pulmonary Hypertension – A condition where blood pressure in the pulmonary arteries becomes abnormally high. The pulmonary arteries carry blood from the heart to the lungs. This increased pressure makes it harder for the heart to pump blood through the lungs. The blood vessels in the lungs become narrowed and thickened over time.

Coronary Microvascular Dysfunction – A condition affecting the small coronary blood vessels that branch off from the larger coronary arteries. These tiny vessels don’t function properly, leading to reduced blood flow to the heart muscle. The small blood vessels may not dilate properly or may have irregular contractions.

Hypoxia – A condition where the body or a specific part of the body doesn’t receive enough oxygen. It occurs when oxygen levels in the blood fall below normal levels. The body’s tissues need oxygen to function properly, and when oxygen levels are too low, cells begin to work less efficiently.

Heart Failure – A chronic condition where the heart cannot pump blood effectively enough to meet the body’s needs. The heart muscle becomes too weak or stiff to work properly. This leads to fluid buildup in the lungs and body tissues, causing symptoms such as shortness of breath and swelling.

Trial ID:
2024-516279-34-00
Protocol code:
PaNaMa code: 113071
Trial Phase:
Therapeutic confirmatory (Phase III)

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