Effectiveness and cost-effectiveness of Ozone therapy in patients with ischemic heart disease with unsuccessful medical and surgical treatment: Randomized, placebo-controlled, clinical trial.

Effectiveness and cost-effectiveness of Ozone therapy in patients with ischemic heart disease refractory to medical and surgical treatment: Randomized, triple-blind clinical trial. - O3Cardio

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000201-24-ES

Enrollment

Registered

2018-06-21

Start date

2018-08-01

Completion date

Unknown

Last updated

2021-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic heart disease refractory to medical and surgical treatment. MedDRA version: 20.0 Level: LLT Classification code 10019279 Term: Heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: LLT Classification code 10055224 Term: Cardiac ischemia System Organ Class: 100000004849

Interventions

Trade Name: Oxigeno Medicinal Gas Carburos Metálicos Product Name: Oxygen (Ozone) Product Code: O3 Pharmaceutical Form: Rectal solution INN or Proposed INN: Ozone CAS Number: 10028-15-6 Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults with chronic heart failure 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. - Age: 18 to 80 years old - It should be required clinical diagnosis by Cardiology Department and confirmation by cardiac catheterization with coronary angiography. - Ejection Fraction =65 years) yes F.1.3.1 Number of subjects for this age range 9

Exclusion criteria

Exclusion criteria: - Pregnancy at the time of enrollment. - Age 80 years old. - Limited walking ability due to neurologic or orthopedic impairments of the legs - Those who are uncapable to fill in the scales used to measure 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1) To assess the clinical effect and impact on self-perceived health-related quality of life (HRQOL) by addition of Ozone therapy to the standard management of patients with heart failure refractory to medical and surgical treatment. 2) To estimate additional cost and the ratio of cost-effectiveness of adding Ozone therapy to standard treatment.;Secondary Objective: 3) To assess: a) biochemical parameters; b) cardiovascular parameters; c) adverse effects 4) To develop and evaluate the acceptability of a shared decision making (SDM) tool among professionals and patients, about ozone therapy in patients with heart failure refractory to medical and surgical treatment.;Primary end point(s): 1. Main variable will be the punctuation in Quality of Life (QoL) measured by the Minnesota Living with Heart Failure questionnaire. 2. Direct Hospital Cost: hospital resources (medication, tests, medical visits...) and non-health cost (non-sanitary transport, social services...).;Timepoint(s) of evaluation of this end point: These 2 "Primary end points" will be evaluated at 3 timepoints: 1) Basal, 2) at the end of the treatment, 3) at 16 weeks after the end of treatment	—

Measure

Time frame

Main Objective: 1) To assess the clinical effect and impact on self-perceived health-related quality of life (HRQOL) by addition of Ozone therapy to the standard management of patients with heart failure refractory to medical and surgical treatment. 2) To estimate additional cost and the ratio of cost-effectiveness of adding Ozone therapy to standard treatment.;Secondary Objective: 3) To assess: a) biochemical parameters; b) cardiovascular parameters; c) adverse effects 4) To develop and evaluate the acceptability of a shared decision making (SDM) tool among professionals and patients, about ozone therapy in patients with heart failure refractory to medical and surgical treatment.;Primary end point(s): 1. Main variable will be the punctuation in Quality of Life (QoL) measured by the Minnesota Living with Heart Failure questionnaire. 2. Direct Hospital Cost: hospital resources (medication, tests, medical visits...) and non-health cost (non-sanitary transport, social services...).;Timepoint(s) of evaluation of this end point: These 2 "Primary end points" will be evaluated at 3 timepoints: 1) Basal, 2) at the end of the treatment, 3) at 16 weeks after the end of treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1. Quality of life questionnaire: EQ-5D-5L. 2. Quality of life questionnaire: SF-36 3. Montreal Cognitive Assessment (MOCA) questionnaire 4. Biochemical cardiac parameters 5. Biochemical parameters of oxidative stress 6. Biochemical parameters of inflammation 7. Echocardiographic parameters 8. Ischemia tests 9. Six minute walk test (SMWT) 10. Transcranial doppler 11. Hyperspectral image of supraciliary area. 12. Doppler ultrasound of lower limbs arteries 13. Hyperspectral image of lower limbs. 14. To evaluate the toxicity of rectal ozone therapy in these patients. 15. To evaluate the acceptability of a shared decision making (SDM) tool among professionals and patients.;Timepoint(s) of evaluation of this end point: The "Secondary end points" 1 to 13 will be evaluated at 3 timepoints: 1) Basal, 2) at the end of the treatment, 3) at 16 weeks after the end of treatment The "Secondary end points" 14 and 15 will be evaluated at the end of follow-up (16 weeks after the end of treatment).	—

Measure

Time frame

Secondary end point(s): 1. Quality of life questionnaire: EQ-5D-5L. 2. Quality of life questionnaire: SF-36 3. Montreal Cognitive Assessment (MOCA) questionnaire 4. Biochemical cardiac parameters 5. Biochemical parameters of oxidative stress 6. Biochemical parameters of inflammation 7. Echocardiographic parameters 8. Ischemia tests 9. Six minute walk test (SMWT) 10. Transcranial doppler 11. Hyperspectral image of supraciliary area. 12. Doppler ultrasound of lower limbs arteries 13. Hyperspectral image of lower limbs. 14. To evaluate the toxicity of rectal ozone therapy in these patients. 15. To evaluate the acceptability of a shared decision making (SDM) tool among professionals and patients.;Timepoint(s) of evaluation of this end point: The "Secondary end points" 1 to 13 will be evaluated at 3 timepoints: 1) Basal, 2) at the end of the treatment, 3) at 16 weeks after the end of treatment The "Secondary end points" 14 and 15 will be evaluated at the end of follow-up (16 weeks after the end of treatment).

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Countries

Spain

Contacts

Public ContactBernardino Clavo, Un. Investigación

Hospital Dr. Negrín

bernardinoclavo@gmail.com34928449278

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026