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

Phase 1

• Conditions: Ischemic heart disease refractory to medical and surgical treatment.; MedDRA version: 20.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849; MedDRA version: 20.0Level: LLTClassification code 10055224Term: Cardiac ischemiaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-000201-24-ES
• Lead Sponsor: Bernardino Clavo - Hospital Dr. Negrín

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-21
• Last Update Posted: 25 May 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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 < 35%
-Patients who have signed and dated the study 's specific informed consent.
-Pregnant women can not participate in the clinical trial.
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

-Pregnancy at the time of enrollment.
-Age < 18 or > 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified