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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ischaemic heart diseasesOther forms of heart diseaseComplications of surgical and medical care, not elsewhere classified
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The Val-CARD trial tries to answer the question “Does the drug sodium valproate reduce complications affecting the heart and kidneys in patients having heart operations?” Sodium valproate is a drug commonly used in the treatment of epilepsy. Recently it has been shown to protect against heart and kidney damage in laboratory tests. This has led to trials evaluating whether it can prevent heart and kidney damage in patients. We wish to evaluate whether sodium valproate can reduce levels of organ damage following cardiac surgery. We think that valproate works by making cells in the heart and kidney more resistant to any injury that they suffer during surgery due to the heart lung machine.
This will be an unblinded randomised controlled trial. It will have two parts.
• In the first part patients awaiting cardiac surgery will be allocated at random to one of 4 groups. Depending on which group they will be assigned to receive either no treatment (i.e., Standard Care - Group A), treatment with 15mg/kg Sodium Valproate for 1-2 weeks (Group B), treatment with 15mg/kg Sodium Valproate for for 4-6 weeks (Group C) or 25mg/kg Sodium Valproate for 4-6 weeks before their surgery. The aim of this part of the trial is to find a sodium valproate dose that produces changes in blood cells that are associated with resistance to injury, but that has the fewest side-effects.
• In the second part of the trial we will compare our selected sodium valproate dose to the current standard of care, which is no treatment. We will then compare markers of kidney and heart injury in blood between the patients treated with sodium valproate and those receiving standard care to establish whether sodium valproate may have benefits.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Drug;
You can take part if:
You may not be able to take part if:
Participant may not enter trial if ANY of the following apply: 1. Emergency or salvage procedure 2. Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) < 15 mL/min/1.72 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation. 3. Patients with persistent or chronic atrial fibrillation. 4. Patients with acute liver disease. 5. Patients with a family history of severe liver disease. 6. Patients allergic to sodium valproate. 7. Patients with thrombocytopaenia (platelet count < 150x109 per mL). 8. Patients taking long-term Histone Deacetylase Inhibitors such as sodium valproate. 9. Patients taking anti-epileptic medication. 10. Patients diagnosed with a mitochondrial deficiency disorder. 11. Patients with porphyria. 12. Patients with known urea cycle disorders. 13. Women of child bearing potential (WOCBP) are excluded from the study. A woman is defined as being of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. 14. Patients who are participating in another interventional clinical trial. 15. Unable, in the opinion of the investigator, or unwilling to give informed consent protocol. Exclusion criteria for optional MRI study 1. Permanent pacemaker or ICD 2. Brain Aneurysm Clip 3. Implanted neural stimulator 4. Cochlear implant (specific implant must be checked that it is MRI safe) 5. Ocular foreign body (e.g. metal shavings) unless removed 6. Other implanted medical devices: (e.g. Swan Ganz catheter) 7. Insulin pump 8. Retained metal shrapnel or bullet
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of Leicester and funded by BRITISH HEART FOUNDATION .
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for Trial ID: CPMS 38403
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