NCT03660657

Ozone Therapy in Refractory Ischemic Heart Disease.

Effectiveness and Cost-effectiveness of Ozone Therapy in Patients With Ischemic Heart Disease Refractory to Medical and Surgical Treatment: Randomized, Triple-blind Clinical Trial

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Bernardino Clavo, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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: 1. Ozone-Group (n = 9): O3/O2 concentration progressively increased from 10 to 30 µg/ml. 2. 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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
DRUG	Ozone	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.
DRUG	Oxygen	Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 µg/ml (only O2); 40 sessions in 16 weeks.

Timeline

• Start date: 2020-02-26
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2018-09-06
• Last updated: 2022-04-04

Locations

1 site across 1 country: Spain