The addition of trientine-HCL to usual care was well-tolerated in patients with heart failure with reduced ejection fraction (HFrEF), based on findings from the TRACER-HF trial presented May 20 during ESC’s Heart Failure 2023 meeting in Prague. Of note, the 300 mg dose of the oral copper chelator considerably reduced NT-proBNP at four and eight weeks, according to James L. Januzzi Jr., MD, FACC, who presented the findings.

The study enrolled 190 participants from 27 sites in North America and China and randomized them into four groups receiving placebo or trientine-HCL at 300 mg, 150 mg or 50 mg doses twice daily. Each group had approximately 50 participants, of whom the average age was 57.3 years and approximately 20% were women and 90% were Asian. The trial, which launched in December 2019 was suspended from April 2020 to January 2021 as a result of the COVID pandemic and a shift was made in 2021 to focus on enrollment in China. 

The primary study endpoint was the effect of trientine-HCL vs. placebo on proportional change in NT-proBNP from baseline to 12 weeks. “In a mixed effect model for repeated measures, a significant reduction was noted in NT-proBNP at four and eight weeks in the 300 mg study arm,” Januzzi said.

In other key secondary endpoints, researchers saw favorable trends for trientine-HCL compared with placebo in left ventricular (LV) reverse remodeling, six-minute walk distance and KCCQ, especially among the 300 mg dose cohort. Additionally, copper and iron concentrations were not significantly different across treatment arms and blood pressure and heart rate were not significantly affected by the addition of trientine-HCL.

According to Januzzi, the post hoc interaction between treatment response and baseline LVEF ≤30% is compelling but hypothesis generating and he noted that data on secondary endpoints in individuals with LVEF ≤30% are forthcoming. He added that further studies of trientine-HCL in HF are also justified.

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Chelating Agents, Ventricular Remodeling, Ventricular Dysfunction, Left, Pandemics, Iron, Stroke Volume, Copper, Trientine, Heart Failure

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