Triangle CERSI Co-PI Robert Mentz, MD, brought a trialist’s perspective to a debate at the Heart Failure 2026 meeting in Barcelona earlier this year on the use of intravenous (IV) iron for patients with heart failure and iron deficiency.
Iron deficiency is common among patients with heart failure, and clinical studies have found promising signs that IV iron can improve symptoms, physical function, and quality of life. However, four major randomized trials have not demonstrated clear benefits on their primary outcomes related to heart failure hospitalizations and death.
Presenting the counterpoint in the debate, Mentz emphasized that these mixed findings do not mean IV iron lacks value. Rather, they leave important questions that require well-designed clinical trials. He noted that definitive evidence of improved clinical outcomes will be important for changing treatment guidelines and payer policies, even as outcomes measuring how patients function and feel remain meaningful.
Mentz also highlighted several factors that could explain the inconsistent findings. Studies have used different definitions of iron deficiency, types and doses of IV iron, and clinical endpoints. He noted that transferrin saturation, or TSAT, may identify iron deficiency more effectively than ferritin alone. Other unanswered questions involve how long treatment effects last, potential interactions with other heart failure therapies, and the limited evidence available for patients with heart failure with preserved ejection fraction.
Mentz is helping conduct the ongoing ICONIC-HF clinical trial, which uses TSAT to identify eligible patients and could help resolve some of these questions.
The debate illustrates how patient selection, endpoint choice, and other trial design decisions can determine whether a promising treatment produces clear and actionable evidence. These considerations are central to developing efficient, patient-centered clinical trials that can meaningfully inform medical practice.
Link to Meeting Programme: https://esc365.escardio.org/Heart-Failure
