Table 1.
Overview of main clinical trials investigating HF patients with mid‐range LVEF
| Study | Year of pubblication | Enrolment/follow up | Geography | Inclusion criteria | Patient number | Prevalence of HFmrEF | Outcomes for HFmrEF |
|---|---|---|---|---|---|---|---|
| Rickenbacher P. et al.4 | 2017 | 2004–2005; median follow up 794 days | Europe | Symptomatic patients, CHF hospitalization within the last year, and elevated NT‐BNP | 824 | 17% |
Mortality 39.7% (no significant differences) All‐cause hospitalization free survival: P = 0.08 Survival: P = 0.92 HF hospitalization free survival: P = 0.29 |
| Toma M. et al.5 | 2014 | May 2007–August 2010 | America, Europe, Asia, and New Zealand | Inclusion criteria of ASCEND‐HF trial with LVEF recorded | 5687 | 11.9% |
180 day mortality HFrEF vs. HFpEF: HR 0.96 (0.75–1.24); P = 0.77 180 day mortality HFmrEF vs. HFpEF: HR 0.91 (0.66–1.3); P = 0.58 Outcomes (HFrEF, HFmrEF, HFpEF; P value) Length of stay (days): 6 (4–10), 7 (4–10), 7 (5–11); 0.007 30 day all‐cause rehospitalization: 11.7, 13.6, 18.1; <0.001 |
| Solomon S.D. et al.6 | 2005 | March 1999–March 2001; follow up: 38 months | Europe, USA, Canada, South Africa, and Australia | Patients enrolled in CHARM programme | 7599 | 17% (LVEF 42–52%) |
In patients with LVEF 42–52%: All‐cause mortality: 5.2% CV death: 4% Non‐CV death: 1.2% Fatal or non‐fatal MI (1st episode): 1.7% CHF hospitalization: 5.7% Fatal or non‐fatal stroke: 1.3% CV death or CHF hospitalization: 7.9% |
| Solomon S.D. et al.7 | 2016 | August 2006–January 2012; follow up through June 2013 | Americas (USA, Canada, Brazil, Argentina) and Europe (Russia and Georgia) | Patients with HF and LVEF ≥ 45% enrolled in TOPCAT | 3444 |
CV death, aborted cardiac arrest, or hospitalization HF (per 100 patient‐years): EF < 50%: HR 7.2 (6.0–8.7), 50% ≤ EF < 55%: HR 6.0 (5.0–7.0), 55% ≤ EF < 60%: HR 5.5 (4.7–6.4), EF ≥ 60% HR 6.7 (5.9–7.5); P = 0.02 HF hospitalization (per 100 patient‐years): EF < 50%: HR 3.8 (2.9–5.0), 50% ≤ EF < 55%: HR 4.1 (3.3–5.0), 55% ≤ EF < 60%: HR 3.7 (3.0, 4.5), EF ≥ 60% HR 4.9 (4.2–5.6) ; P = 0.79 CV death (per 100 patient‐years): EF < 50%: HR 4.1 (3.2–5.2), 50% ≤ EF < 55%: HR 2.8 (2.2–3.6), 55% ≤ EF < 60%: HR 2.7 (2.2–3.3), EF ≥ 60% HR 2.7 (2.2–3.2); P = 0.002 Death (per 100 patient‐years): EF < 50%: HR 5.6 (4.5–6.8), 50% ≤ EF < 55%: HR 4.0 (3.3–4.8), 55% ≤ EF < 60%: HR 4.3 (3.6–5.0), EF ≥ 60% HR 4.3 (3.7, 4.9); P = 0.004 |
|
| Lund L.H. et al.8 | 2018 | March 1999–March 2001; follow up: 2.9 years | Europe, USA, Canada, South Africa, and Australia | Patients enrolled in the CHARM programme | 7598 | 17% |
Outcomes (HFmrEF vs. HFpEF; HFrEF vs. HFpEF) regardless of any treatment CV death + HF hospitalization: HR 1.00 (0.85–1.17) P = 0.98; HR 1.58 (1.40–1.79) P < 0.001 HF hospitalization: HR 0.94 (0.78–1.13) P = 0.55; HR 1.42 (1.23–1.64) P < 0.001 Recurrent HF hospitalization: HR 1.21 (0.98–1.49) P = 0.07; HR 1.96 (1.65–2.23) P < 0.001 CV death: HR 1.21 (0.98–1.51) P = 0.08; HR 2.20 (1.85–2.61) P < 0.001 All‐cause hospitalization: HR 0.89 (0.81–0.98) P = 0.02; HR 0.99 (0.91–1.08) P = 0.85 All‐cause death: HR 0.98 (0.82–1.19) P = 0.88; HR 1.73 (1.49–2.00) P < 0.001 |
CHF, chronic heart failure; CV, cardiovascular; HF, heart failure; HFmrEF, heart failure with mid‐range ejection fraction; HFpEF, heart failure with preserved ejection fraction; HFrEF, heart failure with reduced ejection fraction; HR, hazard ratio; LVEF, left ventricular ejection fraction; OR, odds ratio.