跳至主要内容
临床试验/NCT07134972
NCT07134972已完成不适用

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

Ekrem Bilal Karaayvaz1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Number of patients who had acute heart failure.

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Study Group

Experimental

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

干预措施: Ozone treatment (Drug)

结局指标

主要结局

Number of patients who had acute heart failure.

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Ekrem Bilal Karaayvaz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ekrem Bilal Karaayvaz

Assistant Professor

Istanbul University

研究点 (1)

Loading locations...

相似试验