Table 1 Open in new tab Baseline...

Parameter	Placebo (n = 12)	FlecIH-103 (safety) (n = 42)	FlecIH-103 (efficacy)
Age (y), mean ± SD	64.2 ± 12.5	58.3 ± 13.6	57.4 ± 16.7	59.5 ± 13.3
Male sex, n (%)	7 (58.3%)	30 (71.4%)	10 (83.3%)	18 (66.7%)
White, n (%)	12 (100.0%)	39 (92.9%)	12 (100.0%)	24 (88.9%)
Weight (kg), mean ± SD	98.1 ± 44.7	92.6 ± 29.5	92.5 ± 37.1	94.5 ± 27.0
Height (kg), mean ± SD	159.1 ± 42.2	173.9 ± 25.9	174.2 ± 34.3	174.4 ± 23.4
Body mass index (kg/m²), mean ± SD	27.7 ± 2.8	26.5 ± 4.0	24.9 ± 3.5	27.2 ± 4.0
Systolic blood pressure (mmHg), mean ± SD	121.1 ± 12.9	123.7 ± 13.8	129.7 ± 17.3	120.6 ± 10.8
Diastolic blood pressure (mmHg), mean ± SD	77.5 ± 9.3	83.3 ± 8.8	84.8 ± 9.5	82.4 ± 9.0
Medical comorbidities
Hypertension, n (%)	5 (41.7%)	9 (21.4%)	1 (8.3%)	7 (25.9%)
Hyperlipidaemia, n (%)	4 (33.3%)	9 (21.4%)	1 (8.3%)	8 (29.6%)
Diabetes, n (%)	0 (0.0%)	4 (9.5%)	1 (8.3%)	3 (11.1%)
Coronary artery disease, n (%)	2 (16.7%)	3 (7.1%)	1 (8.3%)	2 (7.4%)
NYHA HF Class I, n (%)	11 (91.7%)	41 (97.6%)	12 (100.0%)	26 (96.3%)
NYHA HF Class II, n (%)	1 (8.3%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
CHA₂DS₂-VASc score, mean ± SD	2.2 ± 1.7	1.2 ± 1.3	1.1 ± 1.2	1.3 ± 1.4
AF at presentation and previous history
AF duration ≤ 24 h, n (%)	10 (83.3%)	35 (83.3%)	11 (91.7%)	21 (77.8%)
AF symptoms duration (h), mean ± SD	15.0 ± 8.7	16.3 ± 10.3	14.5 ± 7.4	16.5 ± 11.9
Ventricular rate (bpm), mean ± SD	105.0 ± 12.0	114.7 ± 21.9	115.3 ± 22.3	115.6 ± 22.6
First AF episode, n (%)	5 (41.7%)	27 (64.3%)	8 (66.7%)	17 (63.0%)
Recurrent AF, n (%)	5 (41.7%)	14 (33.3%)	4 (33.3%)	9 (33.3%)
Post-ablation AF, n (%)	2 (16.7%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
Previous AF episode, mean ± SD	1.4 ± 0.7	1.9 ± 1.6	2.5 ± 3.0	1.7 ± 0.9

Parameter

Placebo (n = 12)

FlecIH-103 (safety) (n = 42)

FlecIH-103 (efficacy)

Conversion-yes (n = 12)

Conversion-no (n = 27)

Age (y), mean ± SD

64.2 ± 12.5

58.3 ± 13.6

57.4 ± 16.7

59.5 ± 13.3

Male sex, n (%)

7 (58.3%)

30 (71.4%)

10 (83.3%)

18 (66.7%)

White, n (%)

12 (100.0%)

39 (92.9%)

12 (100.0%)

24 (88.9%)

Weight (kg), mean ± SD

98.1 ± 44.7

92.6 ± 29.5

92.5 ± 37.1

94.5 ± 27.0

Height (kg), mean ± SD

159.1 ± 42.2

173.9 ± 25.9

174.2 ± 34.3

174.4 ± 23.4

Body mass index (kg/m²), mean ± SD

27.7 ± 2.8

26.5 ± 4.0

24.9 ± 3.5

27.2 ± 4.0

Systolic blood pressure (mmHg), mean ± SD

121.1 ± 12.9

123.7 ± 13.8

129.7 ± 17.3

120.6 ± 10.8

Diastolic blood pressure (mmHg), mean ± SD

77.5 ± 9.3

83.3 ± 8.8

84.8 ± 9.5

82.4 ± 9.0

Medical comorbidities

Hypertension, n (%)

5 (41.7%)

9 (21.4%)

1 (8.3%)

7 (25.9%)

Hyperlipidaemia, n (%)

4 (33.3%)

9 (21.4%)

1 (8.3%)

8 (29.6%)

Diabetes, n (%)

0 (0.0%)

4 (9.5%)

1 (8.3%)

3 (11.1%)

Coronary artery disease, n (%)

2 (16.7%)

3 (7.1%)

1 (8.3%)

2 (7.4%)

NYHA HF Class I, n (%)

11 (91.7%)

41 (97.6%)

12 (100.0%)

26 (96.3%)

NYHA HF Class II, n (%)

1 (8.3%)

1 (2.4%)

0 (0.0%)

1 (3.7%)

CHA₂DS₂-VASc score, mean ± SD

2.2 ± 1.7

1.2 ± 1.3

1.1 ± 1.2

1.3 ± 1.4

AF at presentation and previous history

AF duration ≤ 24 h, n (%)

10 (83.3%)

35 (83.3%)

11 (91.7%)

21 (77.8%)

AF symptoms duration (h), mean ± SD

15.0 ± 8.7

16.3 ± 10.3

14.5 ± 7.4

16.5 ± 11.9

Ventricular rate (bpm), mean ± SD

105.0 ± 12.0

114.7 ± 21.9

115.3 ± 22.3

115.6 ± 22.6

First AF episode, n (%)

5 (41.7%)

27 (64.3%)

8 (66.7%)

17 (63.0%)

Recurrent AF, n (%)

5 (41.7%)

14 (33.3%)

4 (33.3%)

9 (33.3%)

Post-ablation AF, n (%)

2 (16.7%)

1 (2.4%)

0 (0.0%)

1 (3.7%)

Previous AF episode, mean ± SD

1.4 ± 0.7

1.9 ± 1.6

2.5 ± 3.0

1.7 ± 0.9

Parameter	Placebo (n = 12)	FlecIH-103 (safety) (n = 42)	FlecIH-103 (efficacy)
Age (y), mean ± SD	64.2 ± 12.5	58.3 ± 13.6	57.4 ± 16.7	59.5 ± 13.3
Male sex, n (%)	7 (58.3%)	30 (71.4%)	10 (83.3%)	18 (66.7%)
White, n (%)	12 (100.0%)	39 (92.9%)	12 (100.0%)	24 (88.9%)
Weight (kg), mean ± SD	98.1 ± 44.7	92.6 ± 29.5	92.5 ± 37.1	94.5 ± 27.0
Height (kg), mean ± SD	159.1 ± 42.2	173.9 ± 25.9	174.2 ± 34.3	174.4 ± 23.4
Body mass index (kg/m²), mean ± SD	27.7 ± 2.8	26.5 ± 4.0	24.9 ± 3.5	27.2 ± 4.0
Systolic blood pressure (mmHg), mean ± SD	121.1 ± 12.9	123.7 ± 13.8	129.7 ± 17.3	120.6 ± 10.8
Diastolic blood pressure (mmHg), mean ± SD	77.5 ± 9.3	83.3 ± 8.8	84.8 ± 9.5	82.4 ± 9.0
Medical comorbidities
Hypertension, n (%)	5 (41.7%)	9 (21.4%)	1 (8.3%)	7 (25.9%)
Hyperlipidaemia, n (%)	4 (33.3%)	9 (21.4%)	1 (8.3%)	8 (29.6%)
Diabetes, n (%)	0 (0.0%)	4 (9.5%)	1 (8.3%)	3 (11.1%)
Coronary artery disease, n (%)	2 (16.7%)	3 (7.1%)	1 (8.3%)	2 (7.4%)
NYHA HF Class I, n (%)	11 (91.7%)	41 (97.6%)	12 (100.0%)	26 (96.3%)
NYHA HF Class II, n (%)	1 (8.3%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
CHA₂DS₂-VASc score, mean ± SD	2.2 ± 1.7	1.2 ± 1.3	1.1 ± 1.2	1.3 ± 1.4
AF at presentation and previous history
AF duration ≤ 24 h, n (%)	10 (83.3%)	35 (83.3%)	11 (91.7%)	21 (77.8%)
AF symptoms duration (h), mean ± SD	15.0 ± 8.7	16.3 ± 10.3	14.5 ± 7.4	16.5 ± 11.9
Ventricular rate (bpm), mean ± SD	105.0 ± 12.0	114.7 ± 21.9	115.3 ± 22.3	115.6 ± 22.6
First AF episode, n (%)	5 (41.7%)	27 (64.3%)	8 (66.7%)	17 (63.0%)
Recurrent AF, n (%)	5 (41.7%)	14 (33.3%)	4 (33.3%)	9 (33.3%)
Post-ablation AF, n (%)	2 (16.7%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
Previous AF episode, mean ± SD	1.4 ± 0.7	1.9 ± 1.6	2.5 ± 3.0	1.7 ± 0.9

Table 1

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Baseline characteristics and demographics

Parameter	Placebo (n = 12)	FlecIH-103 (safety) (n = 42)	FlecIH-103 (efficacy)
			Conversion-yes (n = 12)	Conversion-no (n = 27)
Age (y), mean ± SD	64.2 ± 12.5	58.3 ± 13.6	57.4 ± 16.7	59.5 ± 13.3
Male sex, n (%)	7 (58.3%)	30 (71.4%)	10 (83.3%)	18 (66.7%)
White, n (%)	12 (100.0%)	39 (92.9%)	12 (100.0%)	24 (88.9%)
Weight (kg), mean ± SD	98.1 ± 44.7	92.6 ± 29.5	92.5 ± 37.1	94.5 ± 27.0
Height (kg), mean ± SD	159.1 ± 42.2	173.9 ± 25.9	174.2 ± 34.3	174.4 ± 23.4
Body mass index (kg/m²), mean ± SD	27.7 ± 2.8	26.5 ± 4.0	24.9 ± 3.5	27.2 ± 4.0
Systolic blood pressure (mmHg), mean ± SD	121.1 ± 12.9	123.7 ± 13.8	129.7 ± 17.3	120.6 ± 10.8
Diastolic blood pressure (mmHg), mean ± SD	77.5 ± 9.3	83.3 ± 8.8	84.8 ± 9.5	82.4 ± 9.0
Medical comorbidities
Hypertension, n (%)	5 (41.7%)	9 (21.4%)	1 (8.3%)	7 (25.9%)
Hyperlipidaemia, n (%)	4 (33.3%)	9 (21.4%)	1 (8.3%)	8 (29.6%)
Diabetes, n (%)	0 (0.0%)	4 (9.5%)	1 (8.3%)	3 (11.1%)
Coronary artery disease, n (%)	2 (16.7%)	3 (7.1%)	1 (8.3%)	2 (7.4%)
NYHA HF Class I, n (%)	11 (91.7%)	41 (97.6%)	12 (100.0%)	26 (96.3%)
NYHA HF Class II, n (%)	1 (8.3%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
CHA₂DS₂-VASc score, mean ± SD	2.2 ± 1.7	1.2 ± 1.3	1.1 ± 1.2	1.3 ± 1.4
AF at presentation and previous history
AF duration ≤ 24 h, n (%)	10 (83.3%)	35 (83.3%)	11 (91.7%)	21 (77.8%)
AF symptoms duration (h), mean ± SD	15.0 ± 8.7	16.3 ± 10.3	14.5 ± 7.4	16.5 ± 11.9
Ventricular rate (bpm), mean ± SD	105.0 ± 12.0	114.7 ± 21.9	115.3 ± 22.3	115.6 ± 22.6
First AF episode, n (%)	5 (41.7%)	27 (64.3%)	8 (66.7%)	17 (63.0%)
Recurrent AF, n (%)	5 (41.7%)	14 (33.3%)	4 (33.3%)	9 (33.3%)
Post-ablation AF, n (%)	2 (16.7%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
Previous AF episode, mean ± SD	1.4 ± 0.7	1.9 ± 1.6	2.5 ± 3.0	1.7 ± 0.9

Parameter	Placebo (n = 12)	FlecIH-103 (safety) (n = 42)	FlecIH-103 (efficacy)
			Conversion-yes (n = 12)	Conversion-no (n = 27)
Age (y), mean ± SD	64.2 ± 12.5	58.3 ± 13.6	57.4 ± 16.7	59.5 ± 13.3
Male sex, n (%)	7 (58.3%)	30 (71.4%)	10 (83.3%)	18 (66.7%)
White, n (%)	12 (100.0%)	39 (92.9%)	12 (100.0%)	24 (88.9%)
Weight (kg), mean ± SD	98.1 ± 44.7	92.6 ± 29.5	92.5 ± 37.1	94.5 ± 27.0
Height (kg), mean ± SD	159.1 ± 42.2	173.9 ± 25.9	174.2 ± 34.3	174.4 ± 23.4
Body mass index (kg/m²), mean ± SD	27.7 ± 2.8	26.5 ± 4.0	24.9 ± 3.5	27.2 ± 4.0
Systolic blood pressure (mmHg), mean ± SD	121.1 ± 12.9	123.7 ± 13.8	129.7 ± 17.3	120.6 ± 10.8
Diastolic blood pressure (mmHg), mean ± SD	77.5 ± 9.3	83.3 ± 8.8	84.8 ± 9.5	82.4 ± 9.0
Medical comorbidities
Hypertension, n (%)	5 (41.7%)	9 (21.4%)	1 (8.3%)	7 (25.9%)
Hyperlipidaemia, n (%)	4 (33.3%)	9 (21.4%)	1 (8.3%)	8 (29.6%)
Diabetes, n (%)	0 (0.0%)	4 (9.5%)	1 (8.3%)	3 (11.1%)
Coronary artery disease, n (%)	2 (16.7%)	3 (7.1%)	1 (8.3%)	2 (7.4%)
NYHA HF Class I, n (%)	11 (91.7%)	41 (97.6%)	12 (100.0%)	26 (96.3%)
NYHA HF Class II, n (%)	1 (8.3%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
CHA₂DS₂-VASc score, mean ± SD	2.2 ± 1.7	1.2 ± 1.3	1.1 ± 1.2	1.3 ± 1.4
AF at presentation and previous history
AF duration ≤ 24 h, n (%)	10 (83.3%)	35 (83.3%)	11 (91.7%)	21 (77.8%)
AF symptoms duration (h), mean ± SD	15.0 ± 8.7	16.3 ± 10.3	14.5 ± 7.4	16.5 ± 11.9
Ventricular rate (bpm), mean ± SD	105.0 ± 12.0	114.7 ± 21.9	115.3 ± 22.3	115.6 ± 22.6
First AF episode, n (%)	5 (41.7%)	27 (64.3%)	8 (66.7%)	17 (63.0%)
Recurrent AF, n (%)	5 (41.7%)	14 (33.3%)	4 (33.3%)	9 (33.3%)
Post-ablation AF, n (%)	2 (16.7%)	1 (2.4%)	0 (0.0%)	1 (3.7%)
Previous AF episode, mean ± SD	1.4 ± 0.7	1.9 ± 1.6	2.5 ± 3.0	1.7 ± 0.9

There were no statistically significant differences (P > 0.05) in demographics, comorbidities, or AF history between treatment groups or when patients were compared by conversion status.

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