None listed
Conditions
Brief summary
Cardiac dysfunction is common in patients undergoing coronary artery bypass grafting (CABG) surgery. The heart’s intrinsic regenerative capability is related to the presence and function of resident cardiac stem cells, but there are limited ways of improving this capability. We have shown that thiamine analogues increase the profileration of resident cardiac stem cells in-vitro, by stimulating the pentose phosphate pathway. In addtion, we have shown that patients with type 2 diabetes have reduced number and less proliferation of resident cardiac stem cells, due to dysfunction of the pentose phosphate pathway. We aim to translate these findings to humans, by randomising patients undergoing CABG surgery to either short-term high dose thiamine or placebo, with a primary endpoint of the ability of resident cardiac stem cells to proliferate. In addition to the valuable findings of the trial itself, if we show that this approach is successful, this study could directly be used to design a larger clinical outcome driven randomised control trial.
Interventions
Thiamine two 500mg capsules twice daily for 3-5 days prior to surgery. Treatment starts after the surgical list for the following week has been finalised and continues until the day before surgery. Adherence and adverse effects of treatment will be monitored by a pill count, questionnaire and blood tests prior to surgery.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients listed for inpatient coronary artery bypass surgery due to atherosclerotic coronary artery disease and 2. Aged 50 years and over and 3. Left ventricular systolic function normal on echocardiography (ejection fraction more than or equal to 50%) performed during this inpatient stay (or within three months if no myocardial infarction has occurred between date of echocardiogram and date of enrollment).
Exclusion criteria
1. Left ventricular systolic function impaired (echocardiographic ejection fraction < 50%) or 2. Renal failure with creatinine > 200 umol/l or requiring renal replacement therapy or 3. Already taking thiamine supplementation or 4. Previously had an adverse reaction to thiamine, or a supplement or medication containing thiamine or 5. Previous or current history of alcohol related problems. This refers to a previous diagnosis of a medical condition thought to be caused or exacerbated by alcohol, or harmful use of alcohol (International Classification of Diseases version 10 codes F10.0 to F10.9) or 6. Other major medical conditions that, in the opinion of the investigator, would make randomisation of the participant to thiamine unsafe or undesirable.
Outcome results
None listed