Conditions: Heart Failure
Keywords: Heart failure Volume overload Tolvaptan loop diuretics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief summary:
One tolvaptan 15 mg tablet or placebo tablet will be orally administered once daily in the morning for up to 14 days to heart failure patients with volume overload that does not show adequate response to other diuretics such as loop diuretics in order to investigate the effect of tolvaptan on the mid- to long-term prognosis of the target population. The efficacy of tolvaptan during the treatment period will also be investigated.

Detailed description:

Arms:
arm 1: 15 mg arm 2: Placebo

Interventions: intervention 1: Tolvaptan intervention 2: Placebo of tolvaptan
Intervention descriptions: intervention 1: Once-daily oral administration of one tolvaptan 15 mg tablet in the morning intervention 2: Once-daily oral administration of one placebo tablet in the morning

Protocol document: