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Sodium Valproate / Coronary Artery Disease / Cardiac Valve Disease · Phase 1/2 Trial
ClinicalTrials.gov · August 17, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a terminated Phase 1/2 trial registration for sodium valproate in cardiac surgery patients. No results are reported in the registry record, and the study was stopped before planned completion, so no evidence of efficacy, safety, or mechanism can be derived from this source.
Phase 1/2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple; age from 18 Years. Intervention: Group B: Sodium Valproate Treatment; Group C: Sodium Valproate Treatment; Group D: Sodium Valproate Treatment. Compared with: Group A: Control — No Intervention. n = 45. 1 site: United Kingdom.
This is a terminated Phase 1/2 trial registration for sodium valproate in cardiac surgery patients. No results are reported in the registry record, and the study was stopped before planned completion, so no evidence of efficacy, safety, or mechanism can be derived from this source.
No efficacy, safety, or mechanistic results reported in this registry record. Surrogate biomarkers used; clinical hard outcomes (mortality, organ failure rates, functional outcomes) not specified.
No clinical recommendations can be made from a terminated trial with no reported results. Clinicians should await peer-reviewed publications of data, if any, before considering sodium valproate for perioperative organ protection.
This is a Phase 1/2 trial registration with no reported results; the study was terminated before completion, precluding any evidence of efficacy or safety.
As stated by the source record.
Quoted from the source exactly as published.
No clinical recommendations can be made from a terminated trial with no reported results. Clinicians should await peer-reviewed publications of data, if any, before considering sodium valproate for perioperative organ protection.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT03825250). This is a study registration, not published results. Lead sponsor: University of Leicester. Recruitment status: TERMINATED. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 45 participants (ACTUAL). Conditions: Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple. Interventions: DRUG: Sodium Valproate. Primary outcome measures: Change of Serum Creatinine level , Baseline, 2 weeks, 4 weeks, 0-6, 6-12, 24, 48, 72, and 96 hours post-operatively; Change of Serum Troponin I level , Baseline, at 0-6, 6-12, 24, 48 and 72 hours post-operatively. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.