parallel randomized trial

FIGHT

Functional Impact of GLP-1 for Heart Failure Treatment

Design

Randomized: 300
Start year: 2013
Treatment: 25.71 weeks, follow-up 30 weeks
Countries: United States (24 sites)
Sponsor: National Heart, Lung, and Blood Institute (mixed)
Eligibility: age 18 or older; LVEF 40% or less; HF hospitalization within 14 days; furosemide 40 mg/day or more

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	loop diuretic and usual heart failure therapy; lifestyle: none	146	146
A2	Liraglutide 1.8 mg subcutaneous once daily Liraglutide 1.8 mg	loop diuretic and usual heart failure therapy; lifestyle: none	154	154

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Liraglutide 1.8 mg subcutaneous once daily A2	Whole trial ALL
age	mean (years)	59.6	59.9
age	sd (years)	12.2	12.9
asian	n	3	0
black	n	48	67
bmi	median (kg/m2)	32.9	31.4
bmi	q1 (kg/m2)	25.4	27.1
bmi	q3 (kg/m2)	38.9	36.1
female	n	33	31
hispanic	n	11	4
lvef	median (percent)			25
lvef	q1 (percent)			19
lvef	q3 (percent)			33
other race american indian alaska native	n	3	4
other race multiple	n	2	1
other race native hawaiian pacific islander	n	0	0
weight	median (lbs)	216.6	206.1
weight	q1 (lbs)	168.8	178.0
weight	q3 (lbs)	258.7	244.8
white	n	90	82

33 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

All cause mortality (5 lines; O20)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			16 / 146	not stated; randomized; R0022323:Supplement Table S1
A1	events			16 / 146	not stated; randomized; registry:flow
A2	events			19 / 154	not stated; randomized; R0022323:Supplement Table S1
A2 vs A1	hr	1.10	0.57 to 2.14		not stated; randomized; R0022323:Supplement Table S1
A2	events			23 / 154	not stated; randomized; registry:flow

Hospitalization for heart failure (3 lines; O23)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			50 / 146	not stated; randomized; R0022323:Supplement Table S1
A2	events			63 / 154	not stated; randomized; R0022323:Supplement Table S1
A2 vs A1	hr	1.30	0.89 to 1.88		not stated; randomized; R0022323:Supplement Table S1

Heart failure events (2 lines; O23B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				48 / 124	not stated; other; R0024780:Table 5
	A2	events				54 / 123	not stated; other; R0024780:Table 5

Health related quality of life total score (any instrument) (2 lines; O24C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
25.71	A1	change	13.25 units on a scale	22.38		146	not stated; randomized; registry:outcomes
25.71	A2	change	13.44 units on a scale	22.61		154	not stated; randomized; registry:outcomes

Serious adverse events (6 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	27 / 124	not stated; other; R0024780:Table 5
A1	events	26 / 124	not stated; other; R0024780:Table 5
A1	events	33 / 146	not stated; safety; registry:adverse_events
A2	events	22 / 123	not stated; other; R0024780:Table 5
A2	events	21 / 123	not stated; other; R0024780:Table 5
A2	events	33 / 154	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	not stated; randomized; registry:flow
	A2	events				0 / 154	not stated; randomized; registry:flow

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 146	not stated; randomized; registry:flow
	A2	events				0 / 154	not stated; randomized; registry:flow

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	3 / 146	not stated; safety; registry:adverse_events
A1	events	1 / 146	not stated; safety; pancreatitis; registry:adverse_events
A2	events	0 / 154	not stated; safety; registry:adverse_events
A2	events	1 / 154	not stated; safety; pancreatitis; registry:adverse_events

Cardiovascular death or heart failure events (3 lines; O40)

Arm	Statistic	Estimate	95% CI	Events / N	Detail
A1	events			57 / 146	not stated; randomized; R0022323:Supplement Table S1
A2	events			72 / 154	not stated; randomized; R0022323:Supplement Table S1
A2 vs A1	hr	1.30	0.92 to 1.84		not stated; randomized; R0022323:Supplement Table S1

KCCQ clinical summary score change (4 lines; O41)

Week	Arm	Statistic	Estimate	SE or SD	Events / N	Detail
12.86	A1	change	11.72 units on a scale	23.82	146	not stated; randomized; registry:outcomes
12.86	A2	change	13.86 units on a scale	24.99	154	not stated; randomized; registry:outcomes
25.71	A1	change	13.14 units on a scale	23.60	146	not stated; randomized; registry:outcomes
25.71	A2	change	13.79 units on a scale	23.83	154	not stated; randomized; registry:outcomes