THE USE OF COENZYME Q 10 BEFORE HEART SURGERY IN ELDERLY PATIENTS. - The use of CoQ10 in heart surgery

Conditions: Patients (male or female) aged > 70 years, clinically stable, with a diagnosis of severe aortic stenosis with indication to surgery based on echocardiography and left ventricle angiography.
MedDRA version: 12.0Level: LLTClassification code 10049194Term: Stable angina pectoris

Registration Number: EUCTR2009-015826-13-IT

Lead Sponsor: PROF. TIZIANO GHERLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients (male or female) aged > 70 years. To be of sound mind Diagnosis of severe aortic stenosis with indications to surgery based on echocardiography and left ventricle angiography.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Urgency or emergency Coma or absence of conscience at time of surgery Acute myocardial infarction RE-DO Mitral velve disease with indications to surgical repair/replacement. Diagnosis of neoplasia in the last 5 years.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of preoperative CoQ10 administration on myocardial protection in terms of incidence of post-operative major ventricular arrhythmias and in terms of elevation of myocardial enzymes serum levels due to ischemia-reperfusion damage.;Secondary Objective: Evaluation of: ? Postoperative major cardiac adverse effects in study and control groups of patients. ? Quality of life in the follow-up ? Left ventricular contractility and regression of left ventricular hypertrophy in the follow-up.;Primary end point(s): Evaluation of tissue and plasmatic levels of CoQ10 after administration of drug vs placebo

Secondary Outcome Measures