BARCELONA, SPAIN — One year's worth of iron supplementation in patients with chronic heart failure and iron deficiency improves functional capacity, symptoms, and quality of life, according to the results of the CONFIRM HF study.
Presenting the findings earlier this week at the European Society of Cardiology (ESC) 2014 Congress , Dr Piotr Ponikowski (Medical University, Wrocław, Poland) said the strategy, which has now shown benefit in two randomized trials, may be an important, often overlooked, target in improving outcomes in heart-failure patients.
"I truly believe [treating iron deficiency] can reduce the risk of hospitalization due to worsening heart failure," he said during an ESC press conference.
CONFIRM HF was also published simultaneously in the European Heart Journal.
The trial enrolled 304 patients with NYHA class 2–3 heart failure, LVEF <45%, elevated brain natriuretic peptide (BNP), and serum ferritin <100 ng/mL or 100 to 300 ng/mL if transferrin saturation was <20%. Patients were randomized 1:1 to IV ferric carboxymaltose or placebo given at baseline, six, 12, 24, and 36 weeks.
At 24 weeks, patients in the iron-supplementation arm had improved their six-minute-walk test—the trial's primary end point—by a mean of 33 m compared with placebo-treated patients (p=0.002). That difference was sustained out to one year and was consistent across a range of subgroups.
Significant improvements were also seen across a range of secondary end points, from week 24 onward, including NYHA class, self-reported patient global assessment, quality of life, and fatigue score.
Reducing Trips to the Hospital?
A post hoc analysis of recurrent hospitalizations due to worsening HF showed a significant reduction in time to first event among the iron-supplementation patients (hazard ratio 0.39, p=0.009).
In the paper, Ponikowski et al acknowledge that their study was not designed to test the morbidity/mortality aspects of iron-deficiency therapy, "but our results constitute a strong background for such a study to be performed in the near future," they conclude. There’s also a need for other countries and centers to test the concept (both FAIR HF and CONFIRM-HF were conducted in Europe). A US trial, IRONOUT , is currently in the planning stages, they note.
Iron deficiency is common in heart-failure patients, regardless of ejection fraction, affecting as many as half of all HF patients, Ponikowski noted. Asked whether physicians currently look for and treat iron deficiency in their HF patients, Ponikowski said, "I'm sorry to say we don't bother at all."
This is despite the fact that they have easy biomarkers to test for and the means to remedy the problem, plus guidelines that give "a very clear statement that we need to take this into consideration."
Commenting on the study for heartwire , Dr John JV McMurray (University of Glasgow, Scotland) said he does not necessarily agree that heart-failure physicians aren't looking for iron deficiency.
"We do. And in the last European guidelines we made the recommendation that you should, so I look for it, and I try to remedy it, [although] I'm not sure everybody does that."
The only other trial that has looked at this was FAIR HF, with "relatively soft outcomes," so perhaps "not everybody was persuaded enough, which is why it was great to see a confirmatory trial done."
"I'm impressed by this study because it's the second trial to look at this . . . that by and large showed the same effects. When you have two separate studies telling you the same thing, it is hard to ignore that evidence. It's pretty robust. There are fairly large and statistically significant, substantial benefits in symptoms and functional outcomes. So to see that twice makes me think this is the real thing."
Ponikowski disclosed honoraria, consultancy, speaker's bureau funds, and research grants from the trial sponsor, Vifor Pharma. McMurray previously disclosed receiving travel reimbursement from Novartis.
Heartwire from Medscape © 2014
Cite this: Shelley Wood. Iron Supplementation Boosts Function, QoL in HF Patients: CONFIRM HF - Medscape - Sep 04, 2014.