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Ozone Therapy in Refractory Ischemic Heart Disease. (O3Cardio)

Primary Purpose

Ischemic Heart Disease

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ozone
Oxygen
Sponsored by
Bernardino Clavo, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring complementary and integrative medicine, cost-effectiveness ratio, ischemic heart disease, heart failure, ozone therapy, quality of life related to health, shared decision-making tool

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults with ischemic heart disease, Functional Class III-IV from the NYHA, with symptoms in spite of maximal conventional medical treatment and no suitable to further percutaneous or surgical procedures.
  • It should be required clinical diagnosis by the Cardiology Department and confirmation by cardiac catheterization with coronary angiography.
  • Ejection Fraction < 40%
  • Patients who have signed and dated the study 's specific informed consent.
  • Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit, and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first dose of the study drug. up to 14 days after the last one.

Exclusion Criteria:

  • Age < 18 or > 85 years old.
  • Severe valve disease and/or dynamic left ventricular outflow tract obstruction.
  • Pregnancy at the time of enrollment.
  • Limited walking ability due to neurologic or orthopedic impairments of the legs
  • Those who are incapable to fill in the scales used to measure the quality of life variables
  • Cerebral vascular accident (CVA or Transient Ischemic Attack (TIA) within the previous 3 months or carotid stenosis > 80%.
  • Acute myocardial infarction (AMI), Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the previous 3 months.
  • Hemodynamically or clinically unstable patients.
  • Severe or limiting pulmonary diseases.
  • Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal
  • Increased creatinine > 3 times the upper limit of normal or Glomerular Filtration Rate (GFR) < 25 ml/min or who are on chronic renal dialysis.
  • Severe peripheral vascular disease with rest pain or significant chronic wounds.

Uncontrolled cancer disease or severe active systemic infection or HIV.

  • Life expectancy < 4 months
  • Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
  • Known allergy to ozone.
  • Patients who do not meet all the inclusion criteria.

Sites / Locations

  • Dr. Negrin University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ozone Group:

Control Group:

Arm Description

Standard treatment + Ozone therapy (O3/O2)

Standard treatment + Oxygen (O2)

Outcomes

Primary Outcome Measures

Quality of Life (QoL) measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at the end of ozone therapy)
Self-reported evaluation of 21 physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each item is scored from 0 (no affected) to 5 (very much affected). Total range from 0 (best) to 105 (worst)
Direct Hospital Cost (at the end of ozone therapy)
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).

Secondary Outcome Measures

Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36) questionnaire (at the end of ozone therapy)
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Change from Baseline in Montreal Cognitive Assessment (MOCA) questionnaire (at the end of ozone therapy)
Assessment of 8 types of cognitive abilities by a total 30-point test (0 = worst, 30 = best)
Change from Baseline in Biochemical cardiac parameters (High sensitive troponin, pro-brain natriuretic peptide (proBNP)) (at the end of ozone therapy)
Serum levels of high sensitive troponin and proBNP
Change from Baseline in Biochemical parameters of oxidative stress (at the end of ozone therapy)
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)
Serum levels of pro-inflammatory interleukins and TNFalpha
Change from Baseline (by Echocardiograpy) of: left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) (at the end of ozone therapy)
Measurement of volume (in ml) of LVEDV and LVESV.
Change from Baseline (by Echocardiograpy) of left ventricular ejection fraction (LVEF) (at the end of ozone therapy)
Measurement (in percentage) of LVEF
Change from Baseline in Six-minute walk test (6MWT) (at the end of ozone therapy)
Assessment of functional exercise capacity according to the walking distance covered over a time of 6 minutes (in meters)
Change from Baseline in cerebral blood flow by Transcranial doppler (at the end of ozone therapy)
Doppler ultrasound evaluation of systolic and diastolic velocity in middle cerebral arteries (in cm/s)
Change from Baseline in Hyperspectral image of the supraciliary area (at the end of ozone therapy)
Assessment of the percentage of reflectance for each wavelength
Change from Baseline in lower limb blood flow by Doppler ultrasound (at the end of ozone therapy)
Doppler ultrasound evaluation of systolic and diastolic velocity in lower limbs (in cm/s)
Change from Baseline in Hyperspectral image of lower limbs (at the end of ozone therapy)
Assessment of the percentage of reflectance for each wavelength
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at the end of ozone therapy)
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Quality of Life (QoL) measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 32 weeks)
Self-reported evaluation of 21 physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each item is scored from 0 (no affected) to 5 (very much affected). Total range from 0 (best) to 105 (worst)
Direct Hospital Cost (at 32 weeks)
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros)
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at 32 weeks)
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36) questionnaire (at 32 weeks)
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Change from Baseline in Montreal Cognitive Assessment (MOCA) questionnaire (at 32 weeks)
Assessment of 8 types of cognitive abilities by a total 30-point test (0 = worst, 30 = best)
Change from Baseline in Biochemical cardiac parameters (High sensitive troponin, pro-brain natriuretic peptide (proBNP)) (at 32 weeks)
Serum levels of high sensitive troponin and proBNP
Change from Baseline in Biochemical parameters of oxidative stress (at 32 weeks)
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Change from Baseline in Biochemical parameters of inflammation (at 32 weeks)
Serum levels of pro-inflammatory interleukins and TNFalpha
Change from Baseline (by Echocardiograpy) of: left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) (at 32 weeks)
Measurement of volume (in ml) of LVEDV and LVESV.
Change from Baseline (by Echocardiograpy) of left ventricular ejection fraction (LVEF) (at 32 weeks)
Measurement (in percentage) of LVEF
Change from Baseline in Six-minute walk test (6MWT) (at 32 weeks)
Assessment of functional exercise capacity according to the walking distance covered over a time of 6 minutes (in meters)
Change from Baseline in cerebral blood flow by Transcranial doppler (at 32 weeks)
Doppler ultrasound evaluation of systolic and diastolic velocity in middle cerebral arteries (in cm/s)
Change from Baseline in Hyperspectral image of the supraciliary area (at 32 weeks)
Assessment of the percentage of reflectance for each wavelength
Change from Baseline in lower limb blood flow by Doppler ultrasound (at 32 weeks)
Doppler ultrasound evaluation of systolic and diastolic velocity in lower limbs (in cm/s)
Change from Baseline in Hyperspectral image of lower limbs (at 32 weeks)
Assessment of the percentage of reflectance for each wavelength
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at 32 weeks)
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability

Full Information

First Posted
August 23, 2018
Last Updated
April 1, 2022
Sponsor
Bernardino Clavo, MD, PhD
Collaborators
Servicio Canario de Salud, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Fundación Canaria de Investigación Sanitaria, Colegio Oficial de Médicos de Las Palmas, Fundación MAPFRE Guanarteme
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1. Study Identification

Unique Protocol Identification Number
NCT03660657
Brief Title
Ozone Therapy in Refractory Ischemic Heart Disease.
Acronym
O3Cardio
Official Title
Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Ischemic Heart Disease Refractory to Medical and Surgical Treatment: Randomized, Triple-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Very low recruitment. During COVID-19 pandemic these are patients of high risk.
Study Start Date
February 26, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bernardino Clavo, MD, PhD
Collaborators
Servicio Canario de Salud, Red de Investigación en Servicios de Salud en Enfermedades Crónicas, Fundación Canaria de Investigación Sanitaria, Colegio Oficial de Médicos de Las Palmas, Fundación MAPFRE Guanarteme

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of this clinical trial is to evaluate the effectiveness and cost-effectiveness of adding ozone therapy to standard management of patients with advanced ischemic heart disease refractory to medical and surgical treatment.
Detailed Description
This study will evaluate the potential role of ozone therapy added to the standard management of patients with symptomatic refractory ischemic heart disease, III-IV functional class of the classification of the New York Heart Association (NYHA). MAIN OBJECTIVES: 1) to evaluate clinical effect and quality of life related to health (HRQOL) of adding O3 to the standard treatment of these patients. 2) to estimate the additional costs of adding O3 to the standard treatment and to evaluate the cost-effectiveness ratio. SECONDARY OBJECTIVES: 3) To evaluate the evolution of a) biochemical parameters; b) cardiovascular parameters; c) toxicity of O3. 4) Develop and evaluate the acceptability of a shared decision-making (SDM) tool between professionals and patients. METHODOLOGY: Phase II-III clinical trial, randomized, triple-blind. Sample size: 18 patients. TREATMENT: All patients will receive their standard treatment + 40 sessions of rectal insufflation: Ozone-Group (n = 9): O3/O2 concentration progressively increased from 10 to 30 µg/ml. Control-placebo-Group (n = 9): O3/O2 Concentration = 0 µg/ml (only O2). Main Variables: 1) changes in the self-perceived quality of life (Minnesota scale). 2) Direct costs. Secondary Variables: 1) biochemical parameters; 2) Cardiovascular parameters; 3) Side effects. 4) acceptability of patients to a shared decision-making (SDM) tool. Length of treatment: 16 weeks. Follow-up: 16 weeks after completion of O3. Assessments: 1) Pre-O3 (basal), 2) pos-O3 (end of O3), 3) 4 months pos-O3. Planned length of clinical trial: 36 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
complementary and integrative medicine, cost-effectiveness ratio, ischemic heart disease, heart failure, ozone therapy, quality of life related to health, shared decision-making tool

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Standard treatment + ozone therapy (O3/O2) versus Standard treatment + oxygen (O2) as placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking of: patients, cardiologist and cardiac surgeons (clinical assessment), investigators obtaining other parameters (quality of life, biochemical and clinical parameters), investigators for statistical analysis
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozone Group:
Arm Type
Experimental
Arm Description
Standard treatment + Ozone therapy (O3/O2)
Arm Title
Control Group:
Arm Type
Placebo Comparator
Arm Description
Standard treatment + Oxygen (O2)
Intervention Type
Drug
Intervention Name(s)
Ozone
Other Intervention Name(s)
O3
Intervention Description
Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 µg/ml; 40 sessions in 16 weeks.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Other Intervention Name(s)
O2
Intervention Description
Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 µg/ml (only O2); 40 sessions in 16 weeks.
Primary Outcome Measure Information:
Title
Quality of Life (QoL) measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at the end of ozone therapy)
Description
Self-reported evaluation of 21 physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each item is scored from 0 (no affected) to 5 (very much affected). Total range from 0 (best) to 105 (worst)
Time Frame
16 weeks
Title
Direct Hospital Cost (at the end of ozone therapy)
Description
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros).
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at the end of ozone therapy)
Description
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Time Frame
16 weeks
Title
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36) questionnaire (at the end of ozone therapy)
Description
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Time Frame
16 weeks
Title
Change from Baseline in Montreal Cognitive Assessment (MOCA) questionnaire (at the end of ozone therapy)
Description
Assessment of 8 types of cognitive abilities by a total 30-point test (0 = worst, 30 = best)
Time Frame
16 weeks
Title
Change from Baseline in Biochemical cardiac parameters (High sensitive troponin, pro-brain natriuretic peptide (proBNP)) (at the end of ozone therapy)
Description
Serum levels of high sensitive troponin and proBNP
Time Frame
16 weeks
Title
Change from Baseline in Biochemical parameters of oxidative stress (at the end of ozone therapy)
Description
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Time Frame
16 weeks
Title
Change from Baseline in Biochemical parameters of inflammation (at the end of ozone therapy)
Description
Serum levels of pro-inflammatory interleukins and TNFalpha
Time Frame
16 weeks
Title
Change from Baseline (by Echocardiograpy) of: left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) (at the end of ozone therapy)
Description
Measurement of volume (in ml) of LVEDV and LVESV.
Time Frame
16 weeks
Title
Change from Baseline (by Echocardiograpy) of left ventricular ejection fraction (LVEF) (at the end of ozone therapy)
Description
Measurement (in percentage) of LVEF
Time Frame
16 weeks
Title
Change from Baseline in Six-minute walk test (6MWT) (at the end of ozone therapy)
Description
Assessment of functional exercise capacity according to the walking distance covered over a time of 6 minutes (in meters)
Time Frame
16 weeks
Title
Change from Baseline in cerebral blood flow by Transcranial doppler (at the end of ozone therapy)
Description
Doppler ultrasound evaluation of systolic and diastolic velocity in middle cerebral arteries (in cm/s)
Time Frame
16 weeks
Title
Change from Baseline in Hyperspectral image of the supraciliary area (at the end of ozone therapy)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
16 weeks
Title
Change from Baseline in lower limb blood flow by Doppler ultrasound (at the end of ozone therapy)
Description
Doppler ultrasound evaluation of systolic and diastolic velocity in lower limbs (in cm/s)
Time Frame
16 weeks
Title
Change from Baseline in Hyperspectral image of lower limbs (at the end of ozone therapy)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
16 weeks
Title
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at the end of ozone therapy)
Description
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Time Frame
16 weeks
Title
Quality of Life (QoL) measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) (at 32 weeks)
Description
Self-reported evaluation of 21 physical, emotional and socioeconomic ways heart failure can adversely affect a patient's life. Each item is scored from 0 (no affected) to 5 (very much affected). Total range from 0 (best) to 105 (worst)
Time Frame
32 weeks
Title
Direct Hospital Cost (at 32 weeks)
Description
The direct expenses incurred by the hospital in providing services (medication, tests, medical visits...) during the 16 weeks of ozone therapy (in euros)
Time Frame
32 weeks
Title
Change from Baseline in quality of life by the "5-level, 5-dimension EuroQol" (EQ-5D-5L) questionnaire (at 32 weeks)
Description
Self-reported evaluation of: a) 5 physical and emotional items scored in five levels, from 1 (best: I have no problem) to 5 (worst: I have extreme problem or I am unable to…) and b) additional self-assessment of health by a visual analogue scale (0 = worst health patient can imagine, 100 = best health patient can imagine)
Time Frame
32 weeks
Title
Change from Baseline in quality of life by the "Short Form 36-item health survey" (SF-36) questionnaire (at 32 weeks)
Description
Self-reported evaluation of 36 items (0 = worst, 100 = best). Final accumulated total range from 0 (worst) to 100 (best)
Time Frame
32 weeks
Title
Change from Baseline in Montreal Cognitive Assessment (MOCA) questionnaire (at 32 weeks)
Description
Assessment of 8 types of cognitive abilities by a total 30-point test (0 = worst, 30 = best)
Time Frame
32 weeks
Title
Change from Baseline in Biochemical cardiac parameters (High sensitive troponin, pro-brain natriuretic peptide (proBNP)) (at 32 weeks)
Description
Serum levels of high sensitive troponin and proBNP
Time Frame
32 weeks
Title
Change from Baseline in Biochemical parameters of oxidative stress (at 32 weeks)
Description
Serum levels of superoxide dismutase, glutathione, glutathione peroxidase and free radicals
Time Frame
32 weeks
Title
Change from Baseline in Biochemical parameters of inflammation (at 32 weeks)
Description
Serum levels of pro-inflammatory interleukins and TNFalpha
Time Frame
32 weeks
Title
Change from Baseline (by Echocardiograpy) of: left ventricular end-diastolic volume (LVEDV) and left ventricular end-systolic volume (LVESV) (at 32 weeks)
Description
Measurement of volume (in ml) of LVEDV and LVESV.
Time Frame
32 weeks
Title
Change from Baseline (by Echocardiograpy) of left ventricular ejection fraction (LVEF) (at 32 weeks)
Description
Measurement (in percentage) of LVEF
Time Frame
32 weeks
Title
Change from Baseline in Six-minute walk test (6MWT) (at 32 weeks)
Description
Assessment of functional exercise capacity according to the walking distance covered over a time of 6 minutes (in meters)
Time Frame
32 weeks
Title
Change from Baseline in cerebral blood flow by Transcranial doppler (at 32 weeks)
Description
Doppler ultrasound evaluation of systolic and diastolic velocity in middle cerebral arteries (in cm/s)
Time Frame
32 weeks
Title
Change from Baseline in Hyperspectral image of the supraciliary area (at 32 weeks)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
32 weeks
Title
Change from Baseline in lower limb blood flow by Doppler ultrasound (at 32 weeks)
Description
Doppler ultrasound evaluation of systolic and diastolic velocity in lower limbs (in cm/s)
Time Frame
32 weeks
Title
Change from Baseline in Hyperspectral image of lower limbs (at 32 weeks)
Description
Assessment of the percentage of reflectance for each wavelength
Time Frame
32 weeks
Title
Incidence of severe adverse events in accordance with the definition of the Council for International Organizations of Medical Sciences (at 32 weeks)
Description
Number of events that are fatal, life threatening, leading to or prolonging a stay in hospital, or resulting in severe disability
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults with ischemic heart disease, Functional Class III-IV from the NYHA, with symptoms in spite of maximal conventional medical treatment and no suitable to further percutaneous or surgical procedures. It should be required clinical diagnosis by the Cardiology Department and confirmation by cardiac catheterization with coronary angiography. Ejection Fraction < 40% Patients who have signed and dated the study 's specific informed consent. Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit, and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first dose of the study drug. up to 14 days after the last one. Exclusion Criteria: Age < 18 or > 85 years old. Severe valve disease and/or dynamic left ventricular outflow tract obstruction. Pregnancy at the time of enrollment. Limited walking ability due to neurologic or orthopedic impairments of the legs Those who are incapable to fill in the scales used to measure the quality of life variables Cerebral vascular accident (CVA or Transient Ischemic Attack (TIA) within the previous 3 months or carotid stenosis > 80%. Acute myocardial infarction (AMI), Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the previous 3 months. Hemodynamically or clinically unstable patients. Severe or limiting pulmonary diseases. Specific liver enzymes [Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) > 5 times the upper limit of normal Increased creatinine > 3 times the upper limit of normal or Glomerular Filtration Rate (GFR) < 25 ml/min or who are on chronic renal dialysis. Severe peripheral vascular disease with rest pain or significant chronic wounds. Uncontrolled cancer disease or severe active systemic infection or HIV. Life expectancy < 4 months Contraindication or disability for rectal ozone administration or to attend scheduled treatments. Known allergy to ozone. Patients who do not meet all the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Pedro G Serrano-Aguilar, MD, PhD
Organizational Affiliation
Servicio de Evaluación. Servicio Canario de Salud. Spain
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Renata Linertová, PhD
Organizational Affiliation
Servicio de Evaluación. Servicio Canario de Salud. Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernardino Clavo, MD, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Celestina Amador, MD, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco Rodríguez-Esparragón, BSc, PhD
Organizational Affiliation
Dr. Negrín University Hospital, Las Palmas, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norberto Santana-Rodríguez, MD, PhD
Organizational Affiliation
King Faisal Specialist Hospital & Research Center, Riyadh, Kingdom of Saudi Arabia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Negrin University Hospital
City
Las Palmas De Gran Canaria
State/Province
Las Palmas
ZIP/Postal Code
35019
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28097518
Citation
Buyuklu M, Kandemir FM, Set T, Bakirci EM, Degirmenci H, Hamur H, Topal E, Kucukler S, Turkmen K. Beneficial Effects of Ozone Therapy on Oxidative Stress, Cardiac Functions and Clinical Findings in Patients with Heart Failure Reduced Ejection Fraction. Cardiovasc Toxicol. 2017 Oct;17(4):426-433. doi: 10.1007/s12012-017-9400-8.
Results Reference
background
PubMed Identifier
19260079
Citation
Bocci V, Borrelli E, Travagli V, Zanardi I. The ozone paradox: ozone is a strong oxidant as well as a medical drug. Med Res Rev. 2009 Jul;29(4):646-82. doi: 10.1002/med.20150.
Results Reference
background
PubMed Identifier
21575276
Citation
Bocci VA, Zanardi I, Travagli V. Ozone acting on human blood yields a hormetic dose-response relationship. J Transl Med. 2011 May 17;9:66. doi: 10.1186/1479-5876-9-66.
Results Reference
background
PubMed Identifier
25699252
Citation
Bocci V, Valacchi G. Nrf2 activation as target to implement therapeutic treatments. Front Chem. 2015 Feb 2;3:4. doi: 10.3389/fchem.2015.00004. eCollection 2015.
Results Reference
background
PubMed Identifier
12804078
Citation
Clavo B, Perez JL, Lopez L, Suarez G, Lloret M, Rodriguez V, Macias D, Santana M, Morera J, Fiuza D, Robaina F, Gunderoth M. Effect of ozone therapy on muscle oxygenation. J Altern Complement Med. 2003 Apr;9(2):251-6. doi: 10.1089/10755530360623365.
Results Reference
background
PubMed Identifier
15841265
Citation
Clavo B, Catala L, Perez JL, Rodriguez V, Robaina F. Ozone Therapy on Cerebral Blood Flow: A Preliminary Report. Evid Based Complement Alternat Med. 2004 Dec;1(3):315-319. doi: 10.1093/ecam/neh039. Epub 2004 Oct 6.
Results Reference
background
PubMed Identifier
28853025
Citation
Clavo B, Eltobgy K, Caballero E, Abad C, Rodriguez-Esparragon F, Santana-Rodriguez N. Is There a Place for Ozone Therapy in Patients with Heart Failure? Cardiovasc Toxicol. 2017 Oct;17(4):496-497. doi: 10.1007/s12012-017-9423-1. No abstract available.
Results Reference
background
PubMed Identifier
18827966
Citation
Di Filippo C, Marfella R, Capodanno P, Ferraraccio F, Coppola L, Luongo M, Mascolo L, Luongo C, Capuano A, Rossi F, D'Amico M. Acute oxygen-ozone administration to rats protects the heart from ischemia reperfusion infarct. Inflamm Res. 2008 Oct;57(10):445-9. doi: 10.1007/s00011-008-7237-0.
Results Reference
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PubMed Identifier
11797116
Citation
Giunta R, Coppola A, Luongo C, Sammartino A, Guastafierro S, Grassia A, Giunta L, Mascolo L, Tirelli A, Coppola L. Ozonized autohemotransfusion improves hemorheological parameters and oxygen delivery to tissues in patients with peripheral occlusive arterial disease. Ann Hematol. 2001 Dec;80(12):745-8. doi: 10.1007/s002770100377. Epub 2001 Oct 13.
Results Reference
background
PubMed Identifier
22796450
Citation
Martinez-Sanchez G, Delgado-Roche L, Diaz-Batista A, Perez-Davison G, Re L. Effects of ozone therapy on haemostatic and oxidative stress index in coronary artery disease. Eur J Pharmacol. 2012 Sep 15;691(1-3):156-62. doi: 10.1016/j.ejphar.2012.07.010. Epub 2012 Jul 13.
Results Reference
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PubMed Identifier
21446774
Citation
Bocci V, Zanardi I, Travagli V. Ozone: a new therapeutic agent in vascular diseases. Am J Cardiovasc Drugs. 2011;11(2):73-82. doi: 10.2165/11539890-000000000-00000.
Results Reference
background
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2018-000201-24
Description
EU Clinical Trials Register (European Union Clinical Trials Register)
URL
https://reec.aemps.es/reec/public/list.html
Description
Spanish Clinical Studies Registry

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Ozone Therapy in Refractory Ischemic Heart Disease.

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