drugset / Trial / NCT03825250

The Val-CARD Trial

NCT03825250

Phase 1/2 Unknown 122 enrolled University of Leicester
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-11-06
Primary completion
2024-10-07
Completion
2024-10-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Valproate Small molecule 15 mg/kg
Subject Valproate Small molecule 25 mg/kg