Table 2.
Cardiac structure and function in select HFpEF clinical trials enrolling at least 100 patients.
| PARAMOUNT41 | Aldo-DHF37 | RELAX67 | I- PRESERVE24 | CHARMES23 | PEP-CHF8 | Reference Values | |
|---|---|---|---|---|---|---|---|
| N | 292 | 422 | 216 | 745 | 312 | 850 | |
| Key Inclusion Criteria | LVEF 45% NT-pBNP>400 |
LVEF≥50% Echo DD or AF pV02≤25 |
LVEF 50% NT-pBNP>400 pV02<60% pred |
LVEF 45% NSR at echo |
LVEF>40% | LVEF>40% DHF by clin, echo criteria |
|
| Age (years) | 70.6±9.1 | 67 ± 8 | 69,62–77 | 72±7 | 66±11 | 75, 72–79 | |
| Female | 56% | 52% | 48% | 62% | 34% | 56% | |
| LV Structure | |||||||
| EDD (cm) | 4.64±0.48 | 4.65±0.62 | 4.6, 4.3–5.1 | 4.8±0.6 | 5.4±0.7 | 4.6, 4.2–5.1 | - |
| ESD (cm) | 2.99±0.70 | 2.55±0.64 | NA | 3.2±0.7 | 3.6±0.7 | NA | - |
| EDVi (ml/m ) | 61.4±15.4 | NA | NA | 49±14 | NA | NA | >75 |
| ESVi (ml/m ) | 26.5±10.4 | NA | NA | 18±9 | NA | NA | >30 |
| MWT (cm) | 0.91±0.16 | NA | NA | 0.93±0.15 | NA | 1.3 (1.2–1.5) | - |
| LV Mass (g) | 148±43 | NA | NA | 164±48 | 237±91 | NA | - |
| LV Mass Index (g/m2) | 79.1±22.2 | 109±28 | 78, 62–94 | NA | 117±42 | NA | |
| Hypertrophy | 14% | NA | 48% | 29% | NA | NA | |
| RWT | 0.38±0.08 | NA | NA | 0.40±0.08 | NA | NA | <0.42 |
| Concentric form of remodeling | 21% | NA | 46% | 54% | NA | NA | |
| LV geometry | |||||||
| Normal | 72% | NA | NA | 46% | NA | NA | |
| Concentric remodeling | 14% | NA | NA | 25% | NA | NA | |
| Concentric hypertrophy | 7% | NA | NA | 29% | NA | NA | |
| Eccentric hypertrophy | 7% | NA | NA | 0% | NA | NA | |
| LV Systolic Function | |||||||
| EF (%) | 57.7±7.9 | 67 ± 8 | 60, 56–65 | 64±9 | 50, 18–65 | 65 (56–66) | ≥55 |
| LV Diastolic Function | |||||||
| LAVi (ml/m2) | 35.9±13.5 | 28.0±8.4 | 44, 36–59 | - | 41.3±14.7 | NA | 16–29 |
| LA Area (cm2) | 21±5 | - | - | 23±6 | NA | NA | ≤20 |
| LA Diameter (cm) | 3.7±0.5 | NA | NA | NA | NA | 4.5 (4.1–4.8) | <4.0 |
| E/A ratio | 1.1±0.62 | 0.91±0.33 | 1.5, 1.0–2.1 | 1.05±0.74 | 1.1±0.7 | 0.7 (0.6–0.9) | 0.8–1.5 |
| TDI E′ septal (cm/s) | 5.8±2.0 | 5.9±1.3 | 6, 5–8 | 7.2±2.9 | NA | NA | 10.4±2.1 (6.2–14.6) |
| TDI E′ lateral (cm/s) | 7.5±2.8 | - | - | 9.1±3.4 | NA | NA | 12.9±3.5 (5.9–19.9) |
| E/E′ ratio (septal) | 15.9±7.3 | 12.8±4.0 | 16,11–24 | - | NA | NA | ≤8 |
| E/E′ ratio (lateral) | 12.7±7.4 | - | - | 10.0±4.5 | NA | NA | ≤8 |
| Diastolic Dysfxn (y/n) | 92% | 100% | NA | 69% | 67% | NA | |
| None | 8% | 0% | NA | 31% | 33% | NA | |
| Grade 1 | 31% | 77% | NA | 29% | 22% | NA | |
| Grade 2 | 43% | 21% | NA | 36% | 37% | NA | |
| Grade 3 | 18% | 2% | NA | 4% | 7% | NA | |
| Pulmonary Pressure | |||||||
| TR velocity (m/sec) | 2.5±0.4 | NA | 41, 33–53 (RVSP) | 37±13 (RVSP) | NA | NA | <2.9 |
Values in italics were estimated by the author from primary data provided in the referenced manuscripts.
EDD – LV end-diastolic dimension; ESD – LV end-systolic dimension; EDVi – LV end-diastolic volume indexed to BSA; EDVi – LV end-systolic volume indexed to BSA; LVEF - LV ejection fraction; WT – wall thickness; LVMI – LV mass index; RWT – relative wall thickness; FS – fractional shortening; LAVi – left atrial volume indexed to BSA; E wave – peak early diastolic transmitral flow velocity; A wave – peak late diastolic transmitral flow velocity; E′ lateral – peak early diastolic mitral annular tissue velocity at lateral mitral annulus; E′ septal – peak early diastolic mitral annular tissue velocity at septal mitral annulus; TR – tricuspid regurgitation.