Table 1 Open in new tab Design and...

IRONOUT HF³⁸

FAIR-HF³⁹

CONFIRM-HF⁴⁰

EFFECT-HF⁴¹ (2017)

AFFIRM-AHF²⁷

Patients (n)

225

459

301

172

1108

Duration (weeks)

Women

36%

53%

47%

25%

45%

Age, median (years)

Treatment vs. control

Oral IP vs. Placebo

IV FCM vs. Placebo

IV FCM vs. SoC

IV FCM vs. Placebo

Key inclusion criteria

Acute or Chronic

Chronic

Acute

NYHA class

II-IV

II-III

I-IV

LVEF

≤40%

≤45%

<50%

Hb (g/dL)

♀9−13.5;♂9–15

9.5–13.5

<15

≤15

8–15

ID definition

Current ESC HF Guidelines^a

Primary outcome

= Peak VO₂

↑ PGA
↓ NYHA

↑ 6MWD

↑ Peak VO₂

= Recurrent HF hosp or CV death

Key secondary outcomes

= 6MWD

↑ 6MWD

↓ NYHA

= VE/VCO₂

↓ Recurrent CV hosp or CV death

= VE/VCO₂

↑ EQ-5D

↑ PGA

↓ NYHA

= CV death

= NT-proBNP

↑ KCCQ

↓ Fatigue score

↑ PGA

↓ Total HF hosp

= KCCQ-CSS

↑ KCCQ

= NT-proBNP/BNP

↓ Time-to-first HF hosp or CV death

= EQ-5D

↓ Days lost due to HF hosp or CV death

Time to: = All-cause death = CV death = HF death

Risk of first/repeated: = All-cause hosp = CV hosp ↓ HF hosp

Table 1

Open in new tab

Design and results of the randomized controlled trials on iron deficiency in heart failure enrolling >100 patients

	IRONOUT HF³⁸	FAIR-HF³⁹	CONFIRM-HF⁴⁰	EFFECT-HF⁴¹ (2017)	AFFIRM-AHF²⁷
Patients (n)	225	459	301	172	1108
Duration (weeks)	16	24	52	24	52
Women	36%	53%	47%	25%	45%
Age, median (years)	63	67	69	63	71
Treatment vs. control	Oral IP vs. Placebo	IV FCM vs. Placebo	IV FCM vs. Placebo	IV FCM vs. SoC	IV FCM vs. Placebo
Key inclusion criteria
Acute or Chronic	Chronic	Chronic	Chronic	Chronic	Acute
NYHA class	II-IV	II-III	II-III	II-III	I-IV
LVEF	≤40%	≤45%	≤45%	≤45%	<50%
Hb (g/dL)	♀9−13.5;♂9–15	9.5–13.5	<15	≤15	8–15
ID definition	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a
Primary outcome	= Peak VO₂	↑ PGA ↓ NYHA	↑ 6MWD	↑ Peak VO₂	= Recurrent HF hosp or CV death
Key secondary outcomes	= 6MWD	↑ 6MWD	↓ NYHA	= VE/VCO₂	↓ Recurrent CV hosp or CV death
	= VE/VCO₂	↑ EQ-5D	↑ PGA	↓ NYHA	= CV death
	= NT-proBNP	↑ KCCQ	↓ Fatigue score	↑ PGA	↓ Total HF hosp
	= KCCQ-CSS		↑ KCCQ	= NT-proBNP/BNP	↓ Time-to-first HF hosp or CV death
			= EQ-5D		↓ Days lost due to HF hosp or CV death
			Time to: = All-cause death = CV death = HF death
			Risk of first/repeated: = All-cause hosp = CV hosp ↓ HF hosp

	IRONOUT HF³⁸	FAIR-HF³⁹	CONFIRM-HF⁴⁰	EFFECT-HF⁴¹ (2017)	AFFIRM-AHF²⁷
Patients (n)	225	459	301	172	1108
Duration (weeks)	16	24	52	24	52
Women	36%	53%	47%	25%	45%
Age, median (years)	63	67	69	63	71
Treatment vs. control	Oral IP vs. Placebo	IV FCM vs. Placebo	IV FCM vs. Placebo	IV FCM vs. SoC	IV FCM vs. Placebo
Key inclusion criteria
Acute or Chronic	Chronic	Chronic	Chronic	Chronic	Acute
NYHA class	II-IV	II-III	II-III	II-III	I-IV
LVEF	≤40%	≤45%	≤45%	≤45%	<50%
Hb (g/dL)	♀9−13.5;♂9–15	9.5–13.5	<15	≤15	8–15
ID definition	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a	Current ESC HF Guidelines^a
Primary outcome	= Peak VO₂	↑ PGA ↓ NYHA	↑ 6MWD	↑ Peak VO₂	= Recurrent HF hosp or CV death
Key secondary outcomes	= 6MWD	↑ 6MWD	↓ NYHA	= VE/VCO₂	↓ Recurrent CV hosp or CV death
	= VE/VCO₂	↑ EQ-5D	↑ PGA	↓ NYHA	= CV death
	= NT-proBNP	↑ KCCQ	↓ Fatigue score	↑ PGA	↓ Total HF hosp
	= KCCQ-CSS		↑ KCCQ	= NT-proBNP/BNP	↓ Time-to-first HF hosp or CV death
			= EQ-5D		↓ Days lost due to HF hosp or CV death
			Time to: = All-cause death = CV death = HF death
			Risk of first/repeated: = All-cause hosp = CV hosp ↓ HF hosp

6MWD, 6 min walking distance; IP, iron polysaccharide; FCM, ferric carboxymaltose; IV, intravenous; LVEF, left ventricular ejection fraction; Hb, haemoglobin; HF, heart failure; PGA, patient global assessment; NYHA, New York Heart Association; KCCQ, Kansas City Cardiomyopathy Questionnaire; CSS, clinical summary score; BNP, B-type natriuretic peptide; NT-proBNP, N-terminal pro-B-type natriuretic peptide; VE/VCO₂, ventilation/carbon dioxide production; TSAT, transferrin saturation; EQ-5D, European Quality of Life Five Dimension; MLHFQ, Minnesota Living with Heart Failure Questionnaire; CV, cardiovascular; hosp: hospitalization; ESC, European Society of Cardiology.

↑, increased by the intervention vs. control; ↓, decreased by the intervention vs. control; =, no difference with the intervention vs. control.

Ferritin < 100 ng/mL OR ferritin 100–299 ng/mL AND TSAT <20%.

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