The Val-CARD Trial

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The Val-CARD trial aims 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. The investigators wish to evaluate whether treatment with sodium valproate for a short period can reduce levels of organ damage following heart surgery by measuring this in blood tests, exercise tests, a special x-ray measuring body fat content, a walk exercise and muscle strength tests. The investigators now want to establish if sodium valproate works by making the heart and kidney more resistant to any injury that results from the use of the heart lung machine.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass (CPB).

• Able, in the opinion of the investigator, and willing to give informed consent.

Exclusion Criteria:

• Emergency or salvage procedure

• 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.

• Patients with persistent or chronic atrial fibrillation.

• Patients with acute liver disease.

• Personal or family history of severe hepatic dysfunction, especially drug related.

• Patients allergic to sodium valproate.

• Patients with thrombocytopaenia (platelet count <150x109 per mL).

• Patients taking long-term Histone Deacetylase Inhibitors such as sodium valproate.

• Patients taking any of the following medications: antipsychotics, MAO inhibitors, antidepressants and benzodiazepines, Lithium, Olanzepine, Phenobarbital, Primidone, Phenytoin, Carbamazepine, Lamotrigine, Felbamate.

• Patients diagnosed with a mitochondrial deficiency disorder.

• Patients with porphyria.

• Patients with known urea cycle disorders.

• 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.

• Patients who are participating in another interventional clinical trial.

• Unable, in the opinion of the investigator, or unwilling to give informed consent protocol.