Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-05 @ 5:49 PM
Study NCT ID:
NCT03660657
Status:
TERMINATED
Last Update Posted:
2022-04-04
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ozone Therapy in Refractory Ischemic Heart Disease.
Sponsor:
Bernardino Clavo, MD, PhD
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Very low recruitment. During COVID-19 pandemic these are patients of high risk.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
O3Cardio
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:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: