Does taking 5-Aminolevulinic acid with sodium ferrous citrate before coronary artery bypass graft surgery result in increased levels of cellular protective protein haem oxygenase-1 and what is the best dose to achieve this?

Phase 1

• Conditions: Cardioprotection for coronary artery bypass graft surgery; MedDRA version: 20.0Level: LLTClassification code 10017501Term: Functional disturbances following cardiac surgerySystem Organ Class: 100000004863; MedDRA version: 20.0Level: HLTClassification code 10007602Term: Cardiac and vascular procedural complicationsSystem Organ Class: 100000004863; MedDRA version: 21.1Level: PTClassification code 10066123Term: Cardiopulmonary bypassSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]; MedDRA version: 20.1Level: PTClassification code 10051624Term: Myocardial reperfusion injurySystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10018910Term: HaemolysisSystem Organ Class: 10005329 - Blood and lymphatic system disorders

• Registration Number: EUCTR2020-001135-27-GB
• Lead Sponsor: niversity of Oxford / Clinical Trials and Research Governance

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-17
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

•Age > 18 years
•Scheduled for primary, isolated elective (non-emergent) CABG under cardiopulmonary bypass
•Signed informed consent
•Able and willing to comply with all study requirements

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

•Female participants who are pregnant, or breast feeding, or either unable or unwilling to use highly effective contraception if of child-bearing potential (under 55 years)
•Acute or chronic types of porphyria
•Known genetic haemochromatosis or clinically significant iron overload
•History of clinically significant photosensitization
•Current long-term (> 3 months) use of amiodarone
•Concomitant use of hypericin extract (including St John’s Wort) or concomitant therapeutic dose oral iron replacement
•History of allergic or adverse reaction to 5-ALA and/or SFC
•Use of other investigational medical product(s) < 28 days prior to study
•Intention to perform concomitant valve surgery (replacement and/or repair), emergency surgery (for catastrophic events) or redo surgery
•Low cardiac output requiring catecholamine infusion and/or mechanical circulatory support prior to induction of anaesthesia for CABG
•Recent acute myocardial infarction (within 3 weeks of surgery) – defined as elevated cardiac troponin > ULN together with symptoms of myocardial ischaemia and/or new ischaemic ECG changes within 2 weeks of surgery
•Coronary surgery without cardiopulmonary bypass (i.e. off pump/OP-CABG) or induced fibrillating heart surgery
•Inadequate renal or liver function defined as any of:
o estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2
o ALT and/or AST > 2.5 x ULN
o total bilirubin > 2 x ULN (unless documented Gilbert’s syndrome)
o known cirrhosis
o known active hepatitis infection
•Any other condition which, in the opinion of the investigator, which makes the patient unsuitable for or may compromise their participation in the study, e.g. due to safety concerns or compliance with clinical study procedures

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified