Table 1. Baseline Characteristics of Participants in a Study of the Effect of Praliciguat on Peak Rate of Oxygen Consumption in Patients With Heart Failure With Preserved Ejection Fraction.
| Characteristic | Mean (SD) | |
|---|---|---|
| 40-mg praliciguat group (n = 91)a | Placebo group (n = 90) | |
| Age, y | 70.7 (9.2) | 70.1 (9.0) |
| Sex, No. (%) | ||
| Women | 35 (38.5) | 40 (44.4) |
| Men | 56 (61.5) | 50 (55.6) |
| Race, No. (%)b | ||
| White | 71 (78.0) | 65 (72.2) |
| Black or African American | 17 (18.7) | 19 (21.1) |
| Asian | 0 | 1 (1.1) |
| Systolic blood pressure, mm Hgc | 133.4 (18.0) | 131.2 (15.5) |
| Diastolic blood pressure, mm Hgc | 74.7 (10.4) | 74.3 (10.7) |
| Heart rate/minc | 67.2 (9) | 67.4 (10.6) |
| BMI | 34.1 (6.1) | 34.7 (7.3) |
| NT-proBNP, median (range), ng/L | 260 (7-4283) | 228.5 (9-5138) |
| Left ventricular ejection fraction, No. (%)d | ||
| ≤50% | 8 (8.8) | 15 (16.7) |
| >50% | 80 (87.9) | 71 (78.9) |
| Atrial fibrillation, No. (%)e | 14 (15.4) | 17 (18.9) |
| New York Heart Association class, No. (%)f | ||
| II | 63 (69.2) | 66 (73.3) |
| III | 28 (30.8) | 24 (26.7) |
| Evidence of heart failure, No. (%)g | ||
| Echocardiographic evidence | 65 (71.4) | 66 (73.3) |
| Elevated BNP or NT-proBNP level | 34 (37.4) | 33 (36.7) |
| Heart failure hospitalization | 28 (30.8) | 31 (34.4) |
| Elevated filling pressures | 18 (19.8) | 17 (18.9) |
| Enrichment eligibility criteria, No. (%)h | ||
| Hypertension | 90 (98.9) | 87 (96.7) |
| Obesity (BMI ≥30) | 71 (78.0) | 64 (71.1) |
| Age ≥70 y | 58 (63.7) | 46 (51.1) |
| Type 2 diabetes/prediabetes | 46 (50.5) | 50 (55.6) |
| 3 of the criteria | 39 (42.8) | 42 (46.7) |
| 2 of the criteria | 29 (31.9) | 29 (32.2) |
| 4 of the criteria | 23 (25.3) | 16 (17.8) |
| NT-proBNP categories, No. (%)i | ||
| ≤300 pg/mL | 52 (57.1) | 50 (55.6) |
| >300 pg/mL | 39 (42.9) | 40 (44.4) |
| Medical history, No. (%)j | ||
| Coronary artery disease | 36 (39.6) | 35 (38.9) |
| Chronic kidney disease | 24 (26.4) | 14 (15.6) |
| Concomitant medication, No. (%) | ||
| Lipid-lowering agent | 72 (79.1) | 66 (73.3) |
| Antiplatelet agent | 63 (69.2) | 60 (66.7) |
| Beta-adrenergic blocker | 42 (46.2) | 47 (52.2) |
| β-Blocker | 39 (42.9) | 24 (26.7) |
| Calcium channel blocker | 28 (30.8) | 26 (28.9) |
| Angiotensin-converting enzyme inhibitor | 27 (29.7) | 36 (40.0) |
| Anticoagulant agent | 21 (23.1) | 17 (18.9) |
| Metformin | 19 (20.9) | 24 (26.7) |
| Diuretic | 17 (18.7) | 17 (18.9) |
| Insulin | 17 (18.7) | 13 (14.4) |
| Glucagon-like peptide 1 receptor agonist | 4 (4.4) | 2 (2.2) |
| Sacubitril/valsartan | 2 (2.2) | 3 (3.3) |
| Sodium glucose co-transporter 2 inhibitor | 2 (2.2) | 1 (1.1) |
Abbreviation: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared).
Data were not available for 1 patient who was randomized but did not receive the study drug.
Patient race was recorded and determined by self-report.
Systolic and diastolic blood pressure and heart rate were assessed at randomization visit.
Left ventricular ejection fraction was assessed by echocardiography; the data presented here reflect the last assessment prior to the start of dosing at the randomization visit.
Atrial fibrillation was defined as history of persistent or permanent atrial fibrillation.
New York Heart Association functional class quantifies clinician-estimated severity of functional limitation. Class I indicates no limiting symptoms; class II, slight limitation; class III, marked symptoms develop with even ordinary activity; and class IV, symptomatic at rest or during minimal activity.
Patient has evidence supporting clinical heart failure syndrome consisting of at least 1 of the following: well-documented hospitalization for heart failure within 12 months; N-terminal fragment of brain natriuretic peptide (NT-proBNP) greater than 300 pg/mL or brain natriuretic peptide of at least 100 pg/mL within 6 months; echocardiographic evidence (≥2 of the following findings: left ventricular hypertrophy, left atrial enlargement, or diastolic dysfunction [medial E/e prime ratio ≥15]) within 12 months; or elevated pulmonary capillary wedge pressure at rest (≥15 mm Hg) or with exercise (>25 mm Hg) or left ventricular end-diastolic pressure of at least 15 mm Hg within 12 months. Of note, hospitalization or emergency department visit were collected as 1 criteria, and numbers of heart failure hospitalizations or emergency department visits individually cannot be assessed.
Included patient population was enriched by at least 2 of the listed 4 conditions with potentially impaired nitric oxide–soluble guanylate cyclase-cyclic guanosine monophosphate signaling.
NT-proBNP levels higher than 300 pg/mL were considered elevated.
Medical history data were determined by study investigators based on medical record review.