Table 1.
Baseline characteristics of patients included in FAIR-HFpEF
| Placebo/saline (n = 21) |
FCM (n = 18) |
|
|---|---|---|
| Sex (women) | 14 (67%) | 10 (56%) |
| Weight (kg) | 83.0 (75.0–90.0) | 83.0 (75.8–87.8) |
| BMI (kg/m2) | 29.8 (26.1–32.5) | 28.9 (26.3–32.4) |
| BMI ≥ 30 kg/m2 | 10 (48%) | 6 (33%) |
| Age (years) | ||
| Mean (SD) | 79 ± 7.03 | 76 ± 8.88 |
| Median (Q1–Q3) | 80 (77–84) | 79 (72–83) |
| LVEF (%) | ||
| Mean (SD) | 55.1 ± 7.8 | 55.3 ± 6.5 |
| Median (Q1–Q3) | 55 (50–56) | 55 (50–60) |
| NYHA class | ||
| II | 10 (48%) | 11 (61%) |
| III | 11 (52%) | 7 (39%) |
| Cause of heart failure | ||
| Ischaemic | 14 (67%) | 9 (50%) |
| Non-ischaemic | 7 (33%) | 9 (50%) |
| Haemodynamics | ||
| Heart rate (b.p.m.) | 68 (61–80) | 68 (60–71) |
| Systolic blood pressure (mmHg) | 125 (111–136) | 127 (113–151) |
| Diastolic blood pressure (mmHg) | 67 (62–72) | 75 (63–80) |
| Laboratory results | ||
| Haemoglobin (g/dL) | 12.0 (11.4–12.8) | 12.9 (11.7–13.2) |
| Serum ferritin (ng/mL) | 50 (25–94) | 44 (23–72) |
| Serum ferritin < 100 ng/mL | 17 (81%) | 15 (83%) |
| TSAT (%) | 16.0 (14.0–21.0) | 19.9 (13.8–24.8) |
| TSAT < 20% | 14 (67%) | 9 (50%) |
| Creatinine (mg/dL) | 1.1 (0.8–1.5) | 1.3 (1.0–1.6) |
| eGFR (mL/min/1.73 m2) | 59 (36–76) | 40 (32–66) (n = 17) |
| Bilirubin (mg/dL) | 0.7 (0.5–0.9) (n = 10) | 0.5 (0.4–0.6)(n = 7) |
| Blood urea nitrogen (mg/dL) | 10 (8–18) (n = 9) | 19 (10–33) (n = 6) |
| ASAT (U/L) | 24 (22–27) | 25 (22–28) |
| ALAT (U/L) | 19 (15–24) | 16 (14–22) |
| γ-GT (U/L) | 27 (17–46) | 31 (19–53) (n = 17) |
| C-reactive protein (mg/L) | 2.9 (1.4–6.0) | 2.1 (1.8–5.0) |
| NT-proBNP (pg/mL) | 490 (343–1331) | 1129 (407–2293) |
| Medical history | ||
| Previous hospitalization for HF | 5 (24%) | 9 (50%) |
| Atrial fibrillation/flutter | 10 (48%) | 10 (56%) |
| Diabetes mellitus | 8 (38%) | 10 (56%) |
| Hypertension | 19 (90%) | 16 (89%) |
| Dyslipidaemia | 14 (67%) | 10 (56%) |
| Coronary artery disease | 14 (67%) | 9 (50%) |
| Previous myocardial infarction | 7 (33%) | 1 (6%) |
| Previous CABG | 2 (10%) | 2 (11%) |
| Previous percutaneous coronary intervention | 12 (57%) | 6 (33%) |
| Valvular heart disease (deemed clinically meaningful) | 12 (57%) | 11 (61%) |
| Treatment | ||
| ACE inhibitor | 13 (62%) | 6 (33%) |
| ARB | 6 (29%) | 5 (28%) |
| ARNi | 0 (0%) | 2 (11%) |
| Beta-blocker | 16 (76%) | 13 (72%) |
| Calcium antagonist | 7 (33%) | 3 (17%) |
| MRA | 7 (33%) | 2 (11%) |
| SGLT2 inhibitor | 4 (19%) | 1 (6%) |
| Any other anti-diabetic | 7 (33%) | 6 (33%) |
| Loop diuretic | 14 (67%) | 15 (83%) |
| Insulin | 3 (14%) | 3 (17%) |
| Any other diuretic | 6 (29%) | 4 (22%) |
| Allopurinol | 5 (24%) | 8 (44%) |
| Proton-pump inhibitor | 11 (52%) | 7 (39%) |
| Cholesterol-lowering drug | 16 (76%) | 10 (56%) |
| Any anti-platelet | 10 (48%) | 7 (39%) |
| Any anticoagulant | 10 (48%) | 9 (50%) |
| Previous ICD | 1 (5%) | 1 (6%) |
| Previous cardiac resynchronization therapy | 3 (14%) | 0 (0%) |
ALAT, alanine aminotransferase; ARB, angiotensin receptor blocker; ARNi, angiotensin receptor-neprilysin inhibitor; ASAT, aspartate aminotransferase; CABG, coronary artery bypass graft; eGFR, estimated glomerular filtration rate; ICD, implantable cardioverter defibrillator; MRA, mineralocorticoid receptor antagonist; γ-GT, γ-glutamyltransferase.