Rationale and design of the FAIR‐HF2‐DZHK05 trial: Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure

European Journal of Heart Failure, Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 28, 2025

Abstract Aims While it is widely accepted that intravenous (IV) iron improves functional capacity, symptoms, and cardiovascular outcomes in patients with heart failure (HF) reduced ejection fraction (HFrEF) diagnosed deficiency (ID), three recently published outcome trials (AFFIRM‐AHF, IRONMAN HEART‐FID) of IV supplementation HF failed to demonstrate a significant benefit on their respective primary endpoints. Dosing after the initial correction baseline ID – by design or as result trial circumstances was relatively low (i.e. <500 mg/year). The objective FAIR‐HF2 evaluate treatment effect ferric carboxymaltose (FCM) compared placebo ambulatory HFrEF using higher dose during follow‐up >1000 second study create prospective evidence for fulfilling new definition HF, i.e. those transferrin saturation <20%. Methods an investigator‐initiated, multicentre, randomized, double‐blind, placebo‐controlled has recruited 1105 chronic left ventricular ≤45% concomitant ID, defined serum ferritin <100 ng/ml 100–299 Patients were consented randomized receive either FCM (treatment) saline (placebo). During estimated median over 2 years, underwent repletion maintenance phase, up 2000 mg, followed 500 mg every 4 months unless stop criteria haemoglobin >16 mg/dl >800 are met repeat visits. will hypotheses: (i) time first event death hospitalization (ii) rate total (first recurrent) hospitalizations (both analysed full population), (iii) <20% at baseline. familywise type I error across endpoint hypotheses be controlled Hochberg procedure (alpha 0.05). Conclusion efficacy improving utilizing more aggressive approach towards ensuring prevention transitional targets have been met.

Language: Английский

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Ferric carboxymaltose assessment of morbidity and mortality in patients with iron deficiency and chronic heart failure (FAIR‐HF2‐DZHK05) trial: Baseline characteristics and comparison to other relevant clinical trials

European Journal of Heart Failure, Journal Year: 2025, Volume and Issue: unknown

Published: April 29, 2025

Aims Prior randomized trials have reported conflicting evidence regarding the efficacy of intravenous (IV) iron in patients with heart failure reduced ejection fraction (HFrEF) and deficiency (ID). Methods results FAIR‐HF2 is a double‐blind, randomized, controlled trial evaluating IV ferric carboxymaltose HFrEF ID. We report baseline characteristics enrolled compare them other major (FAIR‐HF, CONFIRM‐HF, AFFIRM‐AHF, IRONMAN, HEART‐FID). A total 1105 were between March 2017 November 2023. Most men (67%) median age was 72 (interquartile range [IQR] 63–79) years. More than one‐third had hospitalization within preceding 12 months (36%), 53% hospitalized at randomization. Common comorbidities included hypertension (79%), coronary artery disease (74%), dyslipidaemia (67%), diabetes (46%). The left ventricular 58% (IQR 42–77) mean estimated glomerular filtration rate 58 ml/min/1.73 m 2 . 1064 (96%) on renin–angiotensin system inhibitors (angiotensin receptor–neprilysin [ARNI] 38%), 1016 (92%) beta‐blockers, 779 (71%) mineralocorticoid receptor antagonists; 261 (24%) sodium–glucose cotransporter (SGLT2) inhibitors, which much higher prior trials. proportion ischaemic (78%) compared to haemoglobin (g/dl) 12.7 11.8–13.4), serum ferritin (μg/dl) 63 36–90), transferrin saturation (%) 16.5 11.8–22.9), resembling that 6‐min walk distance enrolment 314 ± 118 m. Conclusion represents contemporary cohort mostly similar populations. Use SGLT2 ARNI Clinical Trial Registration: ClinicalTrials.gov ID NCT03036462.

Language: Английский

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Comment on: Intravenous iron for critically ill children. Comparison of three dose regimens

Pediatric Blood & Cancer, Journal Year: 2024, Volume and Issue: 71(4)

Published: Jan. 22, 2024

Language: Английский

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Influence of iron deficiency definition on the efficacy of intravenous iron in heart failure: a meta-analysis of randomized trials

Clinical Research in Cardiology, Journal Year: 2024, Volume and Issue: unknown

Published: Oct. 21, 2024

Abstract Background Intravenous iron improves symptoms in heart failure (HF) with deficiency (ID) but failed to consistently show a benefit cardiovascular outcomes. The ID definition used may influence the response intravenous iron. aim of this meta-analysis is assess on effect HF. Methods/Results We performed random-effects randomized controlled trials (RCT) (vs. placebo or standard care) patients HF and that provided data transferrin saturation (TSAT) ferritin subgroups composite outcome death (CVD) hospitalizations (HFH). risk ratio (RR) 95% confidence intervals (95% CI) were extracted TSAT (< 20% ≥ 20%) 100 ng/mL ng/mL) subgroups. Data from four major RCT was collected including total more than 5500 patients. In < 20%, reduced CVD HFH: RR 0.81, 95%CI 0.69–0.94, while neutral: 0.98, 0.79–1.21, interaction, P = 0.05. On other hand, levels did not modify IV iron: 0.84, 0.65–1.09, 0.85, 0.74–0.97; 0.96. Conclusions Our suggests be restricted regardless supports single use identify who therapy. Graphical abstract > patients, HFH those for treatment neutral. Ferritin, however, had no impact response. This analysis limited irrespective levels. Utilizing therapy should considered.

Language: Английский

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