. 2015 Dec 15;8(12):22117–22128.

Table 1.

Characteristics of the Clinical Trials Included in the Meta-analysis

Trials	Patients Number	Tolvaptan dose	Mean age	Baseline medication	Inclusion criteria	Follow-up	Primary endpoint
Gheorghiade 2003 [17]	254	30 mg/d	67.6±10.9	ACEI/ARB, digoxin, β-blockers, hydralazine/nitrates, furosemide	Irrespective of LVEF, signs of volume overload, (rales, JVD, edema)	25 days	Body weigh changes, adverse event
		45 mg/d	65.6±13.1
		60 mg/d	68.5±13.6
			65.1±12.9 (placebo)
Gheorghiade 2004 [18]	319	30 mg/d	62.0±14.0	ACEI/ARB, digoxin, β-blockers, diuretics, calcium channe blockers, furosemide, intravenous inotropes	LVEF≤40%, systemic congestion evidences (rales, JVD, edema), NHYA classes III to IV	60 days	Body weigh changes, adverse event
		60 mg/d	62.0±13.0
		90 mg/d	62.0±14.0
			60.0±14.0 (placebo)
Gheorghiade 2007 [19]	TralA 2048	30 mg/d	65.8±11.7	ACEI/ARB, digoxin, β-blockers, hydralazine/nitrates, furosemide, diuretics, aldosterone-blocking agent, calcium channe blockers, nesirtide, intravenous inotropes	LVEF≤40%, signs of congestion (dyspnea, JVD, edema)	NG	Global clinical status changes
	TralA 2048	30 mg/d	65.6±11.9 (placebo)
	TralB 2085	30 mg/d	66.0±11.7
	TralB 2085	30 mg/d	65.6±12.2 (placebo)
Konstam 2007 [20]	4133	30 mg/d	65.9±11.7	ACEI/ARB, β-blockers, diuretics, aldosterone-blockers	LVEF≤40%, signs of volume expansion, NHYA classes III to IV	9.9 months	All-cause mortality and cardiovascular death or hospitaliz- -ation heat failure
Konstam 2007 [20]	4133	30 mg/d	65.6±12.0 (placebo)	ACEI/ARB, β-blockers, diuretics, aldosterone-blockers	LVEF≤40%, signs of volume expansion, NHYA classes III to IV	9.9 months
Udelson 2007 [21]	240	30 mg/d	65.0±12.0	ACEI/ARB, β-blockers, diuretics, aldosterone-blockers	LVEF≤30%, NHYA classes II to III	1 year	Symptom changes
Udelson 2007 [21]	240	30 mg/d	63.0±12.0(placebo)	ACEI/ARB, β-blockers, diuretics, aldosterone-blockers	LVEF≤30%, NHYA classes II to III	1 year	Symptom changes
Matsuzaki 2011 [22]	117	15 mg/d	66.9±9.60	Furosemide	Signs of volume overload, (edema, JVD, hepatomegaly, et al.)	NG	Body weigh changes
		30 mg/d	66.4±12.5
		45 mg/d	62.6±12.5
			67.8±9.6 (placebo)
Matsuzaki 2011 [23]	124	15 mg/d	71.3±10.6	Loop diuretic/ thiazide diuretic/ Furosemide, aldosterone-blockers	Signs of volume overload, (edema, JVD, pulmonary congestion,)	27 days	Body weigh changes
Matsuzaki 2011 [23]	124	15 mg/d	71.0±10.9 (placebo)			27 days	Body weigh changes
Hauptamn 2013 [24]	4133	30 mg/d	64.5±13.8	ACEI, β-blockers, diuretics	LVEF≤40%, signs of fluid overload	NG	Body weigh changes, Serum sodium changes
Hauptamn 2013 [24]	4133	30 mg/d	63.6±13.7 (placebo)	ACEI, β-blockers, diuretics	LVEF≤40%, signs of fluid overload	NG	Body weigh changes, Serum sodium changes

D=day; ACEI=Angiotensin-Converting Enzyme Inhibitors; ARB=Angiotensin receptor blocker; LVEF=left ventricular ejection fraction; JVD=jugular venous distention; NHYA=New York Heart Association classification; NG=Not Given.