Table 7.

Conivaptan human studies in heart failure

References	Design	Intervention	Measurements	Number of patients	Condition of patients	Major results
Goldsmith et al48	Double-blind, placebocontrolled, randomized pilot trial	IV conivaptan (20 mg loading dose followed by 40, 80 or 120 mg/d continuous infusion for 2 days	AUC change from baseline at 48 h in patient-assessed severity of respiratory symptoms and global status Total urine output at 72 h The total daily urine output at 24, 48, and 72 h The change from baseline in body weight at 24, 48, and 72 h Patient and clinician global assessments and dyspnea assessments Comparison of clinical signs of heart failure with baseline findings was also recorded.	170	Acute Decompensated HF	Increased total urine output (P = 0.02) and decreased body weight (not significant) Did not improve patient-assessed severity of respiratory symptoms Clinical signs of heart failure were improved consistently in all groups on day 30
Udelson et al71	Double-blinded placebocontrolled randomized trial	Single dose of 10, 20 or 40 mg iv conivaptan	Hemodynamics and urine volume	142	NYHA class II and IV	Reduced PCWP (P < 0.05) and RAP (P < 0.05) when compared to placebo. Increased urine output (P < 0.001) without affecting renal function. There were no significant changes in cardiac index, systemic and pulmonary vascular resistance, blood pressure and heart rate compared to placebo
Russell et al72	Double-blind, placebocontrolled, randomized trial	12-week 10, 20, 40 mg bid oral conivaptan	Exercise time to reach 70% of peak oxygen consumption during an incremental exercise test	345	NYHA class II–IV	No significant differences in exercise tolerance between conivaptan and placebo

Abbreviations: AUC, area under the curve; HF, heart failure; iv, intravenous; NYHA, New York Heart Association; RAP, right atrial pressure; PCWP, pulmonary capillary wedge pressure.