Citation
Cespedes-Suarez J, Martin-Serrano Y,
Carballosa-Peña MR, Dager-Carballosa
DR. Clinical Study of Patients with
Heart Failure under treatment with
Ozone Therapy. J Ozone Ther.
2019:2(3)
doi: 10.7203/jo3t.2.3.2018.11461

Academic Editor
Jose Baeza-Noci,
School of Medicine, Valencia
University, SPAIN

Editor
World Federation of Ozone Therapy,
Bologna, ITALY

Received
February 1, 2018

Accepted
March 24, 2018

Published
December 15, 2018

Intellectual Property
Cespedes-Suarez J.

Cespedes-Suarez J.
This is an open access article
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Creative Commons Attribution License
(CC BY 4 . 0 ) , wh i c h p e rmi t s
unrestricted use, distribution, and
reproduction in any medium, provided
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ORIGINAL ARTICLE

Clinical Study of Patients with Heart Failure under treatment with Ozone Therapy

Javier Cespedes-Suarez, Yanisley Martin-Serrano, Maria Rosa Carballosa-Peña, Diana Rosa Dager-Carballosa

Cardiozono Medical Center, Luanda, Angola

Heart failure (HF) is framed in one of the types of cardiovascular diseases; it
consists of an acute and chronic form. The disease can evolve slowly from
asymptomatic left ventricular dysfunction, to a state of severe disability,
presenting a wide prevalence in the population around 10% in people over
70 years old. More than three-quarters of the deaths from this pathology
normally occur in low or middle-income countries. Angola is not exempt from
this health problem be observed in a relatively young people, bringing
disability and death at an early stage of life. Scientific advances and
innovative treatments for the control and prevention of the disease continue
to be insufficient.
The ozone for it’s antioxidant, hemorehological properties, oxygenation
enhancers and blood circulation is an alternative treatment for these
patients.
We have performed a study where 45 patients who were diagnosed with a
chronic stage of II-III HF due to the functional classification of the New York
Heart Association (NYHA) and American Cardiology College / American
Heart Association (ACC / AHA), previous echocardiogram with a Fracture of
Left Ventricular Ejection (LVEF) less than 45%. We administered a Major
Autohemotherapy with a protocol of 15 sessions, maintenance every 15
days and cycles every 6 months at 50 μg of concentration, an initial dose of
4,000 μg / mL up to 12,000 μg / mL during the 3 years of treatment.
Patients after the first treatment cycle improve their functional physical
capacity and LVEF increased to normal levels (55%). It was proved that
Autohemotherapy is an adjuvant, viable and beneficial treatment in chronic
HF.

Keywords: Heart failure, major autohemotherapy, ozone therapy, left ventricular ejection
fraction

Introduction
Heart failure (HF) is a worldwide public health problem in developed
countries, approximately 2% of the adult population has HF, a prevalence
that increases exponentially with age, as it is less than 1% before the 50
years and then doubles with each decade to exceed 8% among those over
75 years [1,2].

HF is the inability of the heart to pump blood properly according to the needs
of the hepatic metabolism; if it succeeds, it does so at the expense of an
abnormal elevation of the filling pressure of the cardiac ventricles either by
myocardial disease or excessive overload. This brings with it a
neurohormonal response with effort intolerance, fluid retention and reduced
longevity.
In 2003, the American Heart Association (AHA) reported that 48 million
hospital discharges occurred in the United States with this diagnosis [3]. In
the Framingham study, HF in men aged 50-59 years was 8 per 1,000
inhabitants and increasing to 70 per 1,000 in patients over 80 years (very
similar numbers in women) [4].
However, in Africa it has a rather different etiology to that described in
Europe and America, it is related to the degree of development of the
continent and affects predominantly a young population. Damasceno, in his
study on heart failure in Africa, throughout a meta-analysis including studies
published up to 2007 by Bongani Mayosi et al. [5] found that arterial
hypertension was the main cause of heart failure followed by
cardiomyopathies.
The current therapeutic approach of patients with HF is aimed at improving
signs and symptoms, correcting volume overload, increasing end-organ
perfusion, improving cardiac contractility and hemodynamic status [6].
During the last 24 years, the mechanisms of action of ozone in human blood
have been clarified [7]. It is stated that its therapeutic properties are:
improving the metabolism of oxygen, modulate biological oxidative stress,
modulate the immune system, intervene in the synthesis and / or release of
autacoids (endogenous substances with diverse actions physiological and
pharmacological), regulate metabolism, in addition to exert a great effect as
germicide [8].
For all of the above, our team decided to analyze the clinical and
echocardiographic (LVEF) effects induced by major autohemotherapy
applied in patients with CHF.

Materials and methods
A retrospective cross-sectional study was performed at the Cardiozono
Medical Center located in Luanda, Angola. The final sample consisted of 45
patients of both sexes, who presented a diagnosis of CHF, referred from our
Cardiology Department and other Hospital offices, who started treatment of
ozone therapy indistinctly in the period from June 2014 to June 2017. We
emphasize that in our work we performed an analysis of the patients treated
in this time period of their evolution corresponding to one year performing
the therapy.

Inclusion criteria were:
Patients with a diagnosis of HFC class II-III of the New York Heart
Association (NYHA) [9] and American Cardiology College / American Heart
Association (ACC / AHA), previous echocardiography with a (LVEF) between
35% and 50% and patients with a time greater than 6 months of treatment
with furosemide 40 mg at 8 hours and 40 mg at 16 hours, spironolactone 50
mg every 12 hours, hydrochlorothiazide 25 mg daily, carvedilol 12.5 mg
every 12 hours, mononitrate of isosorbide 20 mg daily and aspirin 100 mg
daily. During the period of time analyzed. 45 patients were included in the treatment, 20 were women and 25 men, the age of the patients was from 40
to 65 years, (60 to 65 years, 20 patients, 11 women and 9 men, from 50 to
59 years, 20 patients, 13 men and 7 women and from 40 to 49 years old, 5
patients, 3 men and 2 women).

Exclusion criteria were:

Patients with HF of a diagnosis (less than 6 months) with medical treatment
and patients with secondary HF produced by autoimmune diseases.

Treatment Protocol:

The patients received 15 sessions of major autohemotherapy (one daily
session). In each session we used a German-made Promedic Humazon
equipment (Humares GmbH, Bruchsal, Germany), 3-way stopcock,
epicranial needle 19 G, Sangiset (Humares GmbH, Bruchsal, Germany) with
capacity of 350 mL where we put 10 mL of 3.13 % sodium citrate to avoid
blood clot during the procedure and other disposable material.
The major autohemotherapy (Table 1) was performed at a concentration of
50 μg / mL in 100 m of blood; the initial dose of the therapy was 4000 μg (80
mL of ozone gas at 50 μg / mL concentration); we increased the dose by
2000 μg every 2 days until reaching a dose of 12000 μg (240 mL of ozone
gas at 50 μg / mL concentration), maintaining this dose as a maintenance
dose every 15 days throughout the year.
The parameters evaluated were:
• Heart failure Functional Classification according NYHA [9] (New York Heart
Association) (Table 2)
• Ejection Fraction Classification according NYHA [9]:
– Ejection fraction NORMAL ≈ 50-70% is expelled during each contraction
(there is usually a sense of comfort during physical activities)
– Ejection fraction LIMIT ≈ 41-49% is expelled during each contraction
(symptoms may be more noticeable during physical activity)
– Reduced ejection fraction ≤ 40% is expelled during each contraction
(symptoms may be more noticeable at rest)
DOI: 10.7203/jo3t.2.3.2018.11461
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Table 1: Ozone Treatment protocol

The parameters evaluated were:
• Heart failure Functional Classification according NYHA [9] (New York Heart
Association) (Table 2)
• Ejection Fraction Classification according NYHA [9]:
– Ejection fraction NORMAL ≈ 50-70% is expelled during each contraction
(there is usually a sense of comfort during physical activities)
– Ejection fraction LIMIT ≈ 41-49% is expelled during each contraction
(symptoms may be more noticeable during physical activity)
– Reduced ejection fraction ≤ 40% is expelled during each contraction
(symptoms may be more noticeable at rest)

Tabla 2. Functional Classification of NYHA (New York Heart Association) HF.

Statistical analysis:
We used SPSS 19.0 statistic software and we categorized the values using
contingency tables utility and chi-square analysis for the significance on the
changes before and after the treatment. Values of chi-square under 0,05
were considered significant.

Results and Discussion
The NYHA functional classification assesses the physical activity of the
patient with CHF, based on the subjective assessment made by the
physician during the examination of the presence and severity of dyspnoea.
This has an important prognostic value since it allows following the evolution
and response to the treatment [9].
During ozone therapy, we observed that most of the patients were in class III
for 66.7% of the patients before starting the treatment. At 45 days after the
15 sessions, a significant change was observed, with 86.7% cases in class
II, results that remained in progress throughout the year under treatment
until reaching 53.3% of them to class I. (Table 3).
This process suggests that the response of the organism to
autohemotherapy with the doses used was favorable, although it is not able
to eradicate the disease; it tends to significantly improve the functional
limitations of HF, which agrees with similar studies [10].
The ejection fraction was assessed during different stages of our study
(Table 4). Before starting treatment, most patients had an LVEF of 35-40 for
22.2%, and 44.4% had a Fraction of Erection of 45-50 per year, attributing
the effects of ozone on the contractile function of the myocardium, which improves the metabolism of the cardiac muscle, increases the circulating
serotonin and causes a cardioprotective effect already mentioned in previous
studies [11,12].
Conclusions
This study strongly suggests that the application of major autohemoterapy
produced a clinical and functional improvement in patients with CHF,
evidencing its effectiveness as adjuvant therapy.
References
1. Krumholz HM, Chen YT, Wang Y, Vaccarino V, Radford MJ, Horwitz RI.
Predictors of readmission among elderly survivors of admission with
heart failure. Am Heart J. 2000;139(1):72-77.
2. Cowie MR. Annotated references in epidemiology. Eur J Heart Fail.
1999;1:101-107.
3. Ho KK, Pinsky JL, Kannel WB, Levy D. The epidemiology of heart failure:
the Framingham Study. J Am Coll Cardiol. 1993;22(4 Supl A):6-13.
4. McKee PA, Castelli WP, McNamara PM, Kannel WB. The natural history
DOI: 10.7203/jo3t.2.3.2018.11461
Journal of Ozone Therapy, Vol.2, No.3, 2018: !5 / !6

Tabla 3. Behavior of the Functional Classification of HF in 45 patients treated with ozone therapy.

Tabla 4. Eject Fraction Behavior in 45 patients treated with ozone therapy.

Conclusions
This study strongly suggests that the application of major autohemoterapy
produced a clinical and functional improvement in patients with CHF,
evidencing its effectiveness as adjuvant therapy.

References
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Predictors of readmission among elderly survivors of admission with
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1999;1:101-107.
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the Framingham Study. J Am Coll Cardiol. 1993;22(4 Supl A):6-13.
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