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Completed

NCT Number: NCT07134972

The Effect of Ozone Treatment on Coronary Flow Reserve in Patients With Heart Failure Having Reduced Ejection Fraction

The goal of this clinical trial is to determine the effect of ozone treatment in heart failurte with reduced ejection fraction. The main questions it aims to answer are:

Does ozone treatment have beneficial effects in heart failure patients? What medical problems do heart failure patients have when taking ozone treatment? Researchers will compare ozone treatment in patients with heart failure to ozone treatment in patients with no heart failure (control group) as well as before and after the ozone treatment in patients with heart failure to see if ozone works to treat heart failure.

Participants will:

Give blood samples Take 6-minute walk test Be perfomed Echocardiography with CFR (Coronary Flow Reserve) Take drug ABC or a placebo every day for 4 months Visit the clinic twice a week for ozone treatment for 2 months Give blood samples (after the ozone treatment) Take 6-minute walk test (after the ozone treatment) Be perfomed Echocardiography with CFR (Coronary Flow Reserve) (after the ozone treatment)

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicana International Hospital Istanbul

Istanbul, Turkey (Türkiye)

About this study

Patients who were previously scheduled for ozone therapy at the ozone therapy clinic of Medicana International Hospital Istanbul for another indication that did not affect the endothelial function of coronary arteries were included in the study. Patients with diseases or conditions that may affect endothelial function such as diabetes mellitus, chronic renal failure, thyroid or liver dysfunction, inflammatory diseases or smoking were excluded. Thirty-eight patients with non-ischemic cardiomyopathy who underwent coronary angiography in the Cardiology Department of Medicana International Hospital Istanbul and had less than 50% stenosis and less than 40% ejection fraction (EF) on transthoracic echocardiography were included in the study. All participants were taking beta-blockers, ACEi and mineralocorticoid receptor antagonists for the treatment of heart failure. A control group of 22 people with similar age, sex and demographic properties and no chronic disease has included to the study.

After the patients were enrolled in the study, blood samples were taken and 6-minute walk test, CFR measurement and transthoracic echocardiography were performed. They were then sent for ozone therapy. Two months later, after ozone therapy, blood samples were taken and 6-minute walk test, CFR measurement and transthoracic echocardiography were performed again.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previosuly known coronary angiography with less than % 50 stenosis
  • Echocardiography with ejection fraction of less than % 40
  • Patients with previosly planned for ozone treatment for non-chronic disease or conditions

Exclusion criteria

  • Known chronic diseases or conditions that effect endothelial functions.
  • Previosly had acute coronary syndrome or stent implantation or any coronary intervention.
  • Smokers

Treatment and study plan

Ozone treatment

Drug

Ozone treatment was administered to study group only. 90 ml of blood was collected into a vacuum sterile glass bottle (Ozonosan). To prevent clotting, 10 ml of 3.8% Na Citrate solution was added to the glass vial. The blood to citrate volume ratio is 9:1. After blood collection, the O3 concentration is ozonized to 20-50 mcg/ml. After at least 5 minutes of mixing, ozonized blood was infused over 20 minutes. Ozone/oxygen mixture was administered intravenously. Ozone therapy was administered twice a week for a total of 16 sessions.

Other names: Ozone therapy

Primary outcomes

  1. Number of patients who had acute heart failure.

    Time frame: From start of the treatment to 2 months after the treatment

    The ozone treatment is used for heart failure in this study. If any patient had acute heart failure episode, whether it is drug related or not, that patient can no longer participate in the study.

Sponsors and collaborators

Lead sponsor

Ekrem Bilal Karaayvaz

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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