Table 3.

Baseline characteristics of the real-world HFpEF cohort according to eligibility for PARAGON-HF.

Characteristic	Missed Inclusion Criteria (±Fulfilled Excl. Criteria) (Cohort 2) n = 175	Real-World PARGON-HF (Cohort 1) n = 170	Fulfilled Inclusion and Met Exclusion Criteria (Cohort 3) n = 82	p-Value	Cohort 2–Cohort 1 p-Value	Cohort 1–Cohort 3 p-Value	Cohort 2–Cohort 3 p-Value
Clinical parameters
Age—years	70.2 ± 9.4	73.3 ± 7.4	72.8 ± 7.1	0.001	0.001	0.586	0.030
Female sex—no. (%)	128 (73.1)	116 (68.2)	55 (67.1)	0.494	0.317	0.853	0.317
Systolic blood pressure—mmHg	140.6 ± 19.3	143.0 ± 20.6	132.2 ± 24.6	0.001	0.265	0.001	0.008
Heart rate—beats/min	70.7 ± 14.1	71.9 ± 14.0	72.7 ± 14.3	0.552	0.453	0.672	0.306
Body-mass index—kg/m2	29.9 ± 5.8	29.2 ± 5.3	32.0 ± 8.5	0.004	0.254	0.007	0.043
NYHA functional class—no. (%)				<0.001	<0.001	0.065	<0.001
I	11 (6.3)	0 (0.0)	0 (0.0)
II	86 (49.1)	54 (31.8)	15 (18.3)
III	74 (42.3)	105 (61.7)	59 (71.9)
IV	4 (2.3)	11 (6.5)	8 (9.8)
Exercise capacity
6-min walk test (IQR)—m	385 (300–450)	323 (240–383)	252 (165–387)	<0.001	<0.001	0.070	<0.001
Laboratory parameters
Median NT-proBNP (IQR)—pg/mL	582 (264–995)	1376 (802–2146)	2064 (1150–3533)	<0.001	<0.001	0.001	<0.001
Hemoglobin—g/dL	13.0 ± 1.6	12.4 ± 1.5	11.3 ± 2.0	<0.001	<0.001	<0.001	<0.001
Serum creatinine—mg/dL	1.1 ± 0.8	1.2 ± 0.3	1.5 ± 0.7	<0.001	0.291	<0.001	<0.001
Estimated GFR—mL/min/1.73 m2	68.5 ± 25.5	56.2 ± 16.5	47.4 ± 22.3	<0.001	<0.001	0.002	<0.001
Medical history—no. (%)
Hospitalization for HF (before baseline)	8 (4.6)	49 (28.8)	34 (41.5)	<0.001	<0.001	0.045	<0.001
Arterial hypertension	163 (93.1)	159 (93.5)	79 (96.3)	0.637	0.955	0.361	0.382
Atrial fibrillation	90 (51.4)	103 (60.6)	55 (67.1)	0.048	0.098	0.319	0.021
Non-significant coronary artery disease	36 (20.6)	50 (29.4)	25 (30.5)	0.120	0.066	0.884	0.095
Diabetes mellitus type II	48 (27.4)	53 (31.2)	45 (54.9)	<0.001	0.465	<0.001	<0.001
Chronic obstructive pulmonary disease	37 (21.1)	46 (27.1)	33 (40.2)	0.006	0.188	0.037	0.001
Concomitant medications—no. (%)
ACE inhibitors	46 (26.3)	59 (34.7)	22 (26.8)	0.198	0.096	0.210	0.947
Angiotensin receptor blockers	72 (41.1)	64 (37.6)	34 (41.5)	0.740	0.479	0.560	0.990
Beta blockers	121 (69.1)	131 (77.1)	62 (75.6)	0.260	0.115	0.799	0.316
Calcium channel blockers	56 (32.0)	46 (27.1)	21 (25.6)	0.443	0.298	0.807	0.285
Loop diuretics	50 (28.6)	122 (71.8)	69 (84.1)	<0.001	<0.001	0.032	<0.001
Thiazide diuretics	36 (20.6)	63 (37.1)	21 (25.6)	0.003	0.001	0.071	0.377
Mineralocorticoid receptor antagonists	37 (21.1)	87 (51.2)	54 (65.9)	<0.001	<0.001	0.028	<0.001
Echocardiographic parameters
Left ventricular end-diastolic diameter—mm	43.9 ± 5.2	43.5 ± 5.4	43.8 ± 6.3	0.809	0.524	0.670	0.962
Left ventricular ejection fraction—%	60.9 ± 7.9	60.0 ± 7.8	59.5 ± 8.0	0.352	0.241	0.760	0.221
Left ventricular global longitudinal strain—%	−17.1 ± 3.8	−16.4 ± 3.8	−15.7 ± 3.9	0.094	0.193	0.312	0.037
Left ventricular mass index—g/m2	99.4 ± 23.7	100.0 ± 27.1	100.0 ± 29.3	0.977	0.834	0.986	0.886
Interventricular septum—mm	12.7 ± 2.4	12.6 ± 2.5	12.1 ± 2.2	0.235	0.665	0.181	0.083
Left atrial volume index—mL/m2	38.2 ± 14.7	42.5 ± 16.8	45.3 ± 17.8	0.004	0.015	0.181	0.001
E/A ratio	1.4 ± 0.9	1.7 ± 1.0	1.7 ± 0.9	0.021	0.007	0.627	0.122
E/e‘ ratio	13.4 ± 4.7	14.1 ± 5.7	16.4 ± 7.9	0.079	0.415	0.121	0.082
Right ventricular end-diastolic diameter—mm	34.4 ± 6.6	37.6 ± 7.3	39.7 ± 8.5	<0.001	<0.001	0.047	<0.001
Right atrial volume index—mL/m2	31.0 ± 16.9	41.3 ± 28.3	39.4 ± 19.6	<0.001	<0.001	0.741	0.001
TAPSE—mm	19.1 ± 4.7	17.7 ± 4.1	16.6 ± 4.9	0.001	0.007	0.107	0.001
Right ventricular tissue doppler imaging—m/s	0.13 ± 0.04	0.12 ± 0.03	0.10 ± 0.03	<0.001	0.028	0.005	<0.001
Systolic pulmonary arterial pressure—mmHg	50.6 ± 15.9	55.6 ± 16.9	65.1 ± 22.6	<0.001	0.010	0.003	<0.001
Tricuspid regurgitation velocity—m/s	3.1 ± 0.5	3.3 ± 0.6	3.6 ± 0.7	<0.001	0.011	0.010	<0.001
Invasive hemodynamic parameters
Systolic pulmonary artery pressure—mmHg	48.6 ± 17.1	52.0 ± 16.8	60.6 ± 21.6	<0.001	0.099	0.003	<0.001
Diastolic pulmonary artery pressure—mmHg	20.1 ± 7.3	21.0 ± 6.8	25.4 ± 9.1	<0.001	0.312	0.001	<0.001
Mean pulmonary artery pressure—mmHg	31.2 ± 10.2	32.8 ± 9.7	38.2 ± 12.4	<0.001	0.208	0.001	<0.001
Pulmonary artery wedge pressure—mmHg	17.5 ± 5.9	19.5 ± 6.0	22.1 ± 7.2	<0.001	0.007	0.011	<0.001
Left ventricular end diastolic pressure—mmHg	18.5 ± 5.8	19.9 ± 5.6	20.5 ± 6.7	0.071	0.066	0.536	0.048
Right atrial pressure—mmHg	10.4 ± 4.7	12.2 ± 5.6	14.9 ± 6.5	<0.001	0.005	0.003	<0.001
Transpulmonary pressure gradient—mmHg	13.9 ± 8.1	13.3 ± 6.8	15.6 ± 6.9	0.154	0.528	0.039	0.181
Diastolic pulmonary gradient—mmHg	2.7 ± 6.2	1.5 ± 5.0	3.1 ± 5.6	0.114	0.095	0.053	0.665
Pulmonary vascular resistance—dyn·s/cm5	220.1 ± 128.7	219.0 ± 119.9	256.6 ± 158.7	0.167	0.944	0.081	0.108
Cardiac index Thermo—L/min/m2	2.69 ± 0.62	2.74 ± 0.67	2.77 ± 0.78	0.773	0.575	0.827	0.515
Outcome parameters—no. (%)
Composite endpoint	30 (17.1)	65 (38.2)	40 (48.8)	<0.001	<0.001	0.112	<0.001
Hospitalization for heart failure	26 (14.9)	60 (35.3)	36 (43.9)	<0.001	<0.001	0.187	<0.001
Death from cardiac causes	6 (3.4)	23 (13.5)	16 (19.5)	<0.001	0.001	0.219	<0.001
Death from non-cardiac causes	14 (8.0)	18 (10.6)	9 (11.0)	0.642	0.407	0.926	0.436
Death from any causes	20 (11.4)	41 (24.1)	25 (30.5)	<0.001	0.002	0.281	<0.001

Values are given as mean ± standard deviation, or median and interquartile range, or total numbers and percent. Bold numbers indicate statistical significance with p-values < 0.05. GFR indicates glomerular filtration rate; NYHA, New York Heart Association; NT-proBNP, N-terminal prohormone of brain natriuretic peptide; IQR, interquartile range; HF, heart failure; ACE, angiotensin converting enzyme; E/e’ ratio, ratio of early transmitral blood velocity to early diastolic mitral annular velocity; TAPSE, tricuspid annular plane systolic excursion.