Table 1 Key trial design features
DELIVER (n = 6,263) | FINEARTS-HF (n = 6,001) | PARAGON-HF (n = 4,796) | |
|---|---|---|---|
Comparison | Dapagliflozin versus placebo | Finerenone versus placebo | Sacubitril/valsartan versus valsartan |
Study type | Randomized, double-blind, clinical trial | Randomized, double-blind, clinical trial | Randomized, double-blind, clinical trial |
Enrollment period | 2018–2021 | 2020–2023 | 2014–2016 |
Global enrollment | 350 sites in 20 countries | 654 sites in 37 countries | 848 sites in 43 countries |
Median follow-up (years) | 2.3 | 2.7 | 2.9 |
Patient population | Patients ≥40 years with HF with NYHA class II–IV functional class symptoms | Patients ≥40 years with HF with NYHA class II–IV functional class symptoms | Patients ≥18 years with HF with NYHA class II–IV functional class symptoms |
Setting of enrollment | Patients could be randomized across ambulatory and hospitalized populations | Patients could be randomized across ambulatory and hospitalized populations | Patients could be screened, but not randomized during hospitalization for HF |
LVEF | >40% | ≥40% | ≥45% |
Cardiac structure and function | Evidence of structural heart disease (that is, left ventricular hypertrophy or left atrial enlargement) | Evidence of structural heart disease (that is, left ventricular hypertrophy or left atrial enlargement) | Evidence of structural heart disease (that is, left ventricular hypertrophy or left atrial enlargement) |
Natriuretic peptides | NT-proBNP ≥600 pg ml−1 (in AF) or NT-proBNP ≥300 pg ml−1 (if not in AF) | NT-proBNP ≥300 pg ml−1 (or BNP ≥100 pg ml−1) within 30 days (in those without a recent worsening HF event) or within 90 days (in those with a recent worsening HF event). Qualifying levels of NT-proBNP or BNP were tripled in AF | NT-proBNP >900 pg ml−1 (in AF) or NT-proBNP >300 pg ml−1 (if not in AF) If recently hospitalized for HF within 9 months, NT-proBNP >600 pg ml−1 (in AF) or NT-proBNP >200 pg ml−1 (if not in AF) |
Body mass index | ≤50 kg m−2 | ≤50 kg m−2 | ≤40 kg m−2 |
Systolic blood pressure | ≥95 mm Hg at screening and at randomization | ≥90 mm Hg at screening and at randomization | ≥110 mm Hg at screening and ≥100 mm Hg at randomization |
Potassium | – | ≤5.0 mmol l−1 at screening and at randomization | ≤5.2 mEq l−1 at screening and ≤5.4 mEq l−1 at randomization |
eGFR | ≥25 ml min−1 per 1.73 m2 at screening | ≥25 ml min−1 per 1.73 m2 at screening and at randomization | ≥30 ml min−1 per 1.73 m2 at screening and ≥25 ml min−1 per 1.73 m2 at randomization and without greater than a 35% reduction in eGFR during either run-in period |
Run-in period | None | None | Single-blind run-in phase with half-target doses of both study drugs |
Primary Endpoint | Cardiovascular death or first worsening HF event | Cardiovascular and total worsening HF events | Cardiovascular death and total HF hospitalizations |
