Heart failure & cardiomyopathiesRandomised controlled trial
Intravenous IRON supplementation in Heart Failure with Preserved Ejection Fraction and iron deficiency (IRON-HFpEF): a comprehensive phase II multicentre placebo-controlled randomized clinical trial
- Randomised controlled trial
- phase II
- multicentre
- placebo-controlled
- open-label extension
Authors' conclusion
In patients with HFpEF and ID without ID-anaemia, FCM did not improve exercise hemodynamics, LV diastolic function, myocardial or skeletal energy homeostasis.
Study context
- Population
- Patients with heart failure with preserved ejection fraction (HFpEF) (LVEF ≥50%) and iron deficiency without iron deficiency (ID)-anaemia, NYHA class II–III
- Participants
- 45 patients
- Comparison
- Ferric carboxymaltose vs placebo
- Primary endpoint
- Pulmonary capillary wedge pressure during multiple levels of exercise
- Follow-up
- 4 months
Primary result
As reported in the abstract
Pulmonary capillary wedge pressure during exercise
Mean change
−1.0 mmHg
95% CI −4 to 2
P = 0.52
FCM vs Placebo
mean change −1.0 mmHg (95% CI −4 to 2); P = 0.52
Further findings
| Outcome | FCM | Placebo | Estimate | P value |
|---|---|---|---|---|
| RVEF | +4 (SD 5) % | −3 (SD 6) % | P = 0.002 | |
| Acetylcholine-mediated microvascular perfusion | +5 (SD 24) a.u. | −16 (SD 25) a.u. | P = 0.04 | |
| 6MWD | +6 (SD 31) m | −13 (SD 31) m | P = 0.06 | |
| 6MWD · after correction for baseline differences | +28 m | P = 0.01 |
Myocardial PCr/ATP ratio, calf muscle PCr recovery time, NT-proBNP, KCCQ
- No change in myocardial PCr/ATP ratio
- P = 0.18
- No change in calf muscle PCr recovery time
- P = 0.11
- No change in NT-proBNP
- P = 0.78
- No change in KCCQ
- P = 0.67
Original publication
Intravenous IRON supplementation in Heart Failure with Preserved Ejection Fraction and iron deficiency (IRON-HFpEF): a comprehensive phase II multicentre placebo-controlled randomized clinical trial. Eur J Heart Fail. Published 18 May 2026. doi:10.1093/ejhf/xuag162
Summarised from the published abstract; every number is checked against it