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

NCT07134972 | Completed

• 1 other identifier: IstanbulU-EBKaraayvaz-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Heart Failure and Reduced Ejection Fraction

Keywords

ozone treatment; heart failure with reduced ejection fraction; coronary flow reserve

Outcome Measures

Primary Outcomes (1)

• Number of patients who had acute heart failure.

  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.

  From start of the treatment to 2 months after the treatment

Study Arms (2)

Control Group

NO INTERVENTION

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

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.

Drug: Ozone treatment

Interventions

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.

Also known as: Ozone therapy

Study Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ekrem Bilal Karaayvaz: lead

Study Sites (1)

Medicana International Hospital Istanbul

Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

• Karaayvaz EB, Guz G. Coronary Flow Reserve Changes after Angiotensin Receptor-Neprilysin Inhibitor Treatment in Heart Failure with Reduced Ejection Fraction. Acta Cardiol Sin. 2023 Nov;39(6):871-878. doi: 10.6515/ACS.202311_39(6).20230619C.

  PMID: 38022415 BACKGROUND

• Sawyer DB. Oxidative stress in heart failure: what are we missing? Am J Med Sci. 2011 Aug;342(2):120-4. doi: 10.1097/MAJ.0b013e3182249fcd.

  PMID: 21747279 BACKGROUND

• Zuchi C, Tritto I, Carluccio E, Mattei C, Cattadori G, Ambrosio G. Role of endothelial dysfunction in heart failure. Heart Fail Rev. 2020 Jan;25(1):21-30. doi: 10.1007/s10741-019-09881-3.

  PMID: 31686283 BACKGROUND

• Katz SD. Mechanisms and implications of endothelial dysfunction in congestive heart failure. Curr Opin Cardiol. 1997 May;12(3):259-64. doi: 10.1097/00001573-199705000-00007.

  PMID: 9243083 BACKGROUND

• Heusch G. Coronary blood flow in heart failure: cause, consequence and bystander. Basic Res Cardiol. 2022 Jan 13;117(1):1. doi: 10.1007/s00395-022-00909-8.

  PMID: 35024969 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• Ekrem Bilal Karaayvaz

  Istanbul University Istanbul Faculty of Medicine, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 21, 2025
• Study Start: January 14, 2024
• Primary Completion: December 21, 2024
• Study Completion: December 21, 2024
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request after the manuscript published
• Access Criteria: Data of this study will be upload to clinicaltrials.gov after publication of the study

Locations

TU (1)