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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-14

Study Completion Date

2024-12-21

Brief Summary

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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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Detailed Description

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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.

Conditions

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Heart Failure and Reduced Ejection Fraction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

In our study only the heart failure group have taken ozone treatment. But control groups diagnostic findings were used to compare effect of the treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Group

This group was given no treatment or medication. They had normal echocardiography. They had no heart failure or chronic diseases.

Group Type NO_INTERVENTION

No interventions assigned to this group

Study Group

Heart failure patients with reduced ejection fraction was administered ozone treatment and diagnosed before and after the treatment to understand ozone treatment's effect.

Group Type EXPERIMENTAL

Ozone treatment

Intervention Type 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.

Interventions

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Ozone treatment

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.

Intervention Type DRUG

Other Intervention Names

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Ozone therapy

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes