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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-015826-13-IT
Enrollment
Unknown
Registered
2009-10-01
Start date
2010-10-07
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 12.0 Level: LLT Classification code 10049194 Term: Stable angina pectoris

Interventions

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: Capsul

Sponsors

PROF. TIZIANO GHERLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026