In short
Clinical trials are investigating Trimetazidine Dihydrochloride in people with heart failure with preserved ejection fraction. These studies aim to check whether it can improve outcomes such as hospitalizations and cardiovascular death, and to evaluate biomarkers linked with prognosis.
Key points
- Clinical trials of Trimetazidine Dihydrochloride are studying people with heart failure with preserved ejection fraction. The main trial in the source data is a Phase 3, interventional study with 468 participants. It compares Trimeductan MR with placebo and looks at time to hospitalization for worsening heart failure or cardiovascular death. The trial also assesses endothelial function and biomarkers linked to prognosis. The study status is completed.
Trial overview
The source data describe one interventional study of Trimetazidine Dihydrochloride in people with heart failure with preserved ejection fraction. The study title says it examined the impact of trimetazidine on endothelial function and biomarkers linked with prognosis in this heart condition.
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. The intervention list shows two groups: Trimeductan MR, 35 mg modified-release tablets, and placebo. A placebo is an inactive comparison treatment used to help researchers judge whether the study drug makes a difference.
Who participated
The trial enrolled people with heart failure with preserved ejection fraction. The source data do not provide more detailed inclusion or exclusion rules, so the exact participation criteria cannot be listed here.
What the trial measured
The main outcome was time to hospitalization due to heart failure exacerbation or cardiovascular death. 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. The brief summary also says the study assessed the number of events caused by heart failure worsening or cardiovascular death.
The title also shows that researchers were looking at endothelial function and biomarkers. 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.
Trial status and size
The study status is completed, so the planned trial work has finished. The enrollment was 468 participants, which shows that this was a moderate-size Phase 3 trial.