THE USE OF COENZYME Q 10 BEFORE HEART SURGERY IN ELDERLY PATIENTS.

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ubidecarenone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use CONDITION: 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: 12.0 Level: LLT Classification code 10049194 Term: Stable angina pectoris PRIMARY OUTCOME: 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. Primary end point(s): Evaluation of tissue and plasmatic levels of CoQ10 after administration of drug vs placebo 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. INCLUSION CRITERIA: 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
Epistemonikos ID: 3fb33f6627b11a84b32404d8e4b42bec0aa57227
First added on: Aug 22, 2024