Ozone Therapy in Refractory Ischemic Heart Disease.

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03660657
Study type	Interventional
Source	Dr. Negrin University Hospital
Contact
Status	Terminated
Phase	Phase 2/Phase 3
Start date	February 26, 2020
Completion date	November 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Recruiting	`NCT06002932` - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.	N/A
Active, not recruiting	`NCT04562805` - Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)	N/A
Recruiting	`NCT05292079` - CAPTURER PMCF Study ( rEPIC04D )
Recruiting	`NCT05292118` - Navitian PMCF Study ( rEPIC04C )
Recruiting	`NCT05292092` - Essential Pro PMCF Study ( rEPIC04E )
Recruiting	`NCT05292014` - ANGIOLITE PMCF Study ( rEPIC04F )
Completed	`NCT05292105` - NC Xperience PMCF Study( rEPIC04B)
Completed	`NCT03076801` - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease?	N/A
Not yet recruiting	`NCT04153383` - Milrinone on Cardiac Performance During Off-pump Coronary Artery Bypass Surgery
Recruiting	`NCT02982434` - The New Pharmaceutical Composition Containing Botulinum Toxin to Treat Atrial Fibrillation	Phase 2
Recruiting	`NCT02729064` - Intraoperative Nasal Insulin Effect on Plasma and CSF Insulin Concentration and Blood Glucose	Phase 1
Completed	`NCT02468401` - Prevention of Contrast Induced Nephropathy in Patients With Advanced Renal Dysfunction Undergoing Coronary Interventions	N/A
Completed	`NCT02759406` - Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study	N/A
Recruiting	`NCT01681381` - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization	N/A
Completed	`NCT01699802` - Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)	N/A
Completed	`NCT01604213` - Effects of Vildagliptin/Metformin Combination on Markers of Atherosclerosis, Thrombosis, and Inflammation in Diabetics With Coronary Artery Disease	Phase 4
Completed	`NCT01334268` - RESOLUTE China RCT	N/A
Completed	`NCT01724567` - Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training	N/A
Completed	`NCT02159235` - Heavy Metals, Angiogenesis Factors and Osteopontin in Coronary Artery Disease (CAD)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Ozone Therapy in Refractory Ischemic Heart Disease. — O3Cardio

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms