Table of Contents
- Trial overview
- Study design and treatment groups
- Who participated
- What the trial measured
- Trial status and size
Trial overview
The source data describe one interventional study of Trimetazidine Dihydrochloride in people with heart failure with preserved ejection fraction.[1] The study title says it examined the impact of trimetazidine on endothelial function and biomarkers linked with prognosis in this heart condition.[1]
Study design and treatment groups
This was a Phase 3 trial, which means it was a later-stage study designed to test the treatment in a larger group of patients.[1] The intervention list shows two groups: Trimeductan MR, 35 mg modified-release tablets, and placebo.[1] A placebo is an inactive comparison treatment used to help researchers judge whether the study drug makes a difference.[1]
Who participated
The trial enrolled people with heart failure with preserved ejection fraction.[1] The source data do not provide more detailed inclusion or exclusion rules, so the exact participation criteria cannot be listed here.[1]
What the trial measured
The main outcome was time to hospitalization due to heart failure exacerbation or cardiovascular death.[1] In simple terms, the study wanted to see how long it took before a patient needed hospital care for worsening heart failure or died from a heart and blood vessel problem.[1] The brief summary also says the study assessed the number of events caused by heart failure worsening or cardiovascular death.[1]
The title also shows that researchers were looking at endothelial function and biomarkers.[1] Endothelial function means how well the inner lining of blood vessels works, and biomarkers are measurable signs in the body that may help show disease status or prognosis.[1]
Trial status and size
The study status is completed, so the planned trial work has finished.[1] The enrollment was 468 participants, which shows that this was a moderate-size Phase 3 trial.[1]
